| Primary | Mean Time to Onset of Gastric Emptying | Mean time to onset of gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 microcurie [mcCi] isotope-technetium-99m-diethylene-triamine-pentaacetate [DTPA]). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. Regions of interest (ROI) included the stomach, proximal small intestine, distal small intestine and colon. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | minutes | | Predose until 10 hours post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.107± 1.2130
- OG0018.534± 6.6062
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| Primary | Mean Time to Complete Gastric Emptying | Mean time to complete gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m-DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | minutes | | Predose until 10 hours post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | |
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| Primary | Mean Time for Gastric Emptying by Measuring 25 Percent Values | Mean time to gastric emptying by 25 percent (GE25%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | minutes | | Predose until 10 hours post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Mean Time for Gastric Emptying by Measuring 50 Percent Values | Mean time to gastric emptying by 50 percent (GE50%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | minutes | | Predose until 10 hours post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Mean Time for Gastric Emptying by Measuring 90 Percent Values | Mean time to gastric emptying by 90 percent (GE90%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | minutes | | Predose until 10 hours post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 15 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 30 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 45 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 60 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 75 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 90 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 105 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 120 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 120 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 180 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 180 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Percentage of Radiolabeled Drug Remaining in the Stomach After 240 Minutes of Administration | Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Deviation | percentage of radiolabeled drug | | 240 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 15 Minutes | Area under the gastric emptying curve from time 0 to 15 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 15 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 30 Minutes | Area under the gastric emptying curve from time 0 to 30 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 30 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 45 Minutes | Area under the gastric emptying curve from time 0 to 45 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 45 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 60 Minutes | Area under the gastric emptying curve from time 0 to 60 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 60 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 75 Minutes | Area under the gastric emptying curve from time 0 to 75 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 75 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 90 Minutes | Area under the gastric emptying curve from time 0 to 90 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 90 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 105 Minutes | Area under the gastric emptying curve from time 0 to 105 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 105 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 120 Minutes | Area under the gastric emptying curve from time 0 to 120 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 120 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 180 Minutes | Area under the gastric emptying curve from time 0 to 180 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 180 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Area Under the Gastric Emptying Curve From Time 0 to 240 Minutes | Area under the gastric emptying curve from time 0 to 240 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | 240 minutes post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Total Area Under the Gastric Emptying Curve | Total area under the gastric emptying curve was evaluated by scintigraphic imaging, performed after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Mean | Standard Error | percentage dose*hour | | Predose until 10 hours post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Gastric Emptying Half-Life | Gastric emptying half-life was defined as the time required by the stomach to empty 50% of the ingested meal and was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Median | Full Range | minutes | | Predose until 10 hours post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Primary | Small Intestine Transit Time | Small intestinal transit time was calculated by determining the arrival time of the radiolabeled investigational drug formulation at the cecum or colon region from scintigraphic imaging and subtracting the gastric emptying value. | Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations. | Posted | | Median | Full Range | minutes | | Predose until 10 hours post dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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| Secondary | Number of Participants With Clinically Significant Change in Laboratory Test Values | Haematological, biochemistry, urinalysis and virological parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. | Safety population was defined as all participants who received a radiolabeled Treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. | Posted | | Count of Participants | | Participants | | From baseline up to Day 1 | | | | ID | Title | Description |
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| OG000 | Treatment Group A | Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. | | OG001 | Treatment Group B | Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose. |
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