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The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water. |
|
| Paracetamol tablet | Active Comparator | Two paracetamol 500 mg tablets to be administered with 150 mL of hot water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | Present in both test and active comparator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter) | Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles. | Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min) | AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule. | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIO-IMAGES Research Ltd. | Glasgow | Scotland | G63 0BX | United Kingdom |
Of 37 participants screened, 12 participants did not meet the study criteria. Remaining 25 participants were randomized into the study.
Participants were recruited at one clinical study site in Glasgow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hot Drink Remedy First, Then Standard Paracetamol Tablets | Participants received one sachet of hot drink remedy containing 1000 milligram (mg) paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid in 150 milliliter (mL) of radio-labeled water (first intervention period). After a washout period of minimum two days, a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL water were administered (second intervention period). |
| FG001 | Standard Paracetamol Tablets First, Then Hot Drink Remedy | Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water (first intervention period). After a washout period of minimum two days, one sachet of hot drink remedy with 150 mL of radio-labeled water was administered (second intervention period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I |
| |||||||||||||
| Washout Period |
| |||||||||||||
| Period II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants who received a study treatment during the cross over study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter) | Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles. | Modified Intent-To-Treat (MITT) population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods. | Posted | Median | Full Range | minutes | Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
|
Adverse events were collected from the start of the treatment, and until 5 days following administration of the last dose of investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hot Drink Remedy | Participants then received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid, which was dissolved in 150 mL of radio-labeled water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D010656 | Phenylephrine |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Phenylephrine | Drug | Test product |
|
| Ascorbic Acid | Drug | Test product |
|
| AUC (0-60 Min) |
AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method. |
| Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
| Maximum Plasma Concentration (Cmax) | Cmax was determined using plasma paracetamol concentration time profile. | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
| Time to Maximum Plasma Concentration (Tmax) | Time after administration when the maximum plasma concentration was reached. | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
| Time to Onset of Gastric Emptying | The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets. | Baseline to 10 hours |
| Time to Completion of Gastric Emptying | Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity. | Baseline to 10 hours |
| Time to Onset and Completion of Disintegration of Reference Tablets | Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program. | Baseline to 10 hours post dose |
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| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Standard Paracetamol Tablets |
Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water. |
|
|
|
| Secondary | Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min) | AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule. | MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods. | Posted | Mean | Standard Deviation | nanograms (ng)*hours (h)/mL | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
|
|
|
| Secondary | AUC (0-60 Min) | AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method. | MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) | Cmax was determined using plasma paracetamol concentration time profile. | MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods. | Posted | Mean | Standard Deviation | ng/mL | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) | Time after administration when the maximum plasma concentration was reached. | MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods. | Posted | Median | Full Range | hours | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose |
|
|
|
| Secondary | Time to Onset of Gastric Emptying | The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets. | Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to 10 hours |
|
|
|
| Secondary | Time to Completion of Gastric Emptying | Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity. | Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to 10 hours |
|
|
|
| Secondary | Time to Onset and Completion of Disintegration of Reference Tablets | Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program. | Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Tablet Disintegration endpoints were only measured in the first period for each participant. | Posted | Mean | Standard Deviation | minutes | Baseline to 10 hours post dose |
|
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Standard Paracetamol Tablets | Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water. | 0 | 25 | 3 | 25 |
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Blepharospasm | Eye disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
| Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |