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The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG readings) which could predispose patients to ventricular arrhythmias. This study is conducted to satisfy this requirement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Placebo | Placebo Comparator |
| |
| Cohort 1: 900 mg linezolid | Experimental |
| |
| Cohort 1: 1200 mg linezolid | Experimental |
| |
| Cohort 2: Placebo | Placebo Comparator |
| |
| Cohort 2: 600 mg linezolid | Experimental |
| |
| Cohort 2: 1200 mg linezolid | Experimental |
| |
| Cohort 2: 400 mg Moxifloxacin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Intravenous, Placebo control for blinding, Normal Saline, Single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported. | From the time the subject had taken at least one dose of study treatment up to 5 weeks |
| Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo | The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia's formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available. | 0.5, 1, 2, 4, 8, 12, 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last) | AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Sequence 1 | Subjects were randomly assigned to placebo first, then linezolid 900 milligrams (mg) followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 1. |
| FG001 | Cohort 1: Sequence 2 | Subjects were randomly assigned to linezolid 900 mg first, then placebo, followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 2. |
| FG002 | Cohort 1: Sequence 3 | Subjects were randomly assigned to linezolid 900 mg first, then 1200 mg linezolid, followed by placebo after a washout period of 48 hours between doses in Sequence 3. |
| FG003 | Cohort 2: Sequence 1 | Subjects were randomly assigned to placebo, then moxifloxacin, followed by linezolid 600 mg and 1200 mg, after a washout period of 48 hours between doses in Sequence 1. |
| FG004 | Cohort 2: Sequence 2 | Subjects were randomly assigned to linezolid 600 mg first, then linezolid 1200 mg followed by placebo and moxifloxacin, after a washout period of 48 hours between doses in Sequence 2. |
| FG005 | Cohort 2: Sequence 3 | Subjects were randomly assigned to linezolid 1200 mg first, then moxifloxacin 400 mg followed by linezolid 600 mg and placebo after a washout period of 48 hours between doses in Sequence 3. |
| FG006 | Cohort 2: Sequence 4 | Subjects were randomly assigned to moxifloxacin 400 mg first, then placebo followed by linezolid 1200 mg and 600 mg linezolid after a washout period of 48 hours between doses in Sequence 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 |
| |||||||||||||
| Cohort 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Placebo, Linezolid 900 mg and 1200 mg | Subjects were randomly assigned to placebo followed by linezolid 900 mg then 1200 mg linezolid in Sequence 1; or, linezolid 900 mg then linezolid 1200 mg followed by placebo in Sequence 2; or, linezolid 900 mg then placebo followed by linezolid 1200 mg in Sequence 3. There was a washout period of 48 hours between doses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported. | Safety Analysis Set (SAS): All subjects who received at least 1 dose of study medication. | Posted | Number | participants | From the time the subject had taken at least one dose of study treatment up to 5 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Placebo |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | MedDRA (12.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069349 | Linezolid |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
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| Linezolid 900 mg |
| Drug |
Intravenous, 900 mg linezolid, single dose |
|
|
| Linezolid 1200 mg | Drug | Intravenous, 1200 mg linezolid, single dose |
|
|
| Placebo | Drug | Intravenous, Placebo control for blinding, Normal Saline, Single dose |
|
| Linezolid 600 mg | Drug | Intravenous, 600 mg linezolid, single dose |
|
|
| Linezolid 1200 mg | Drug | Intravenous, 1200 mg linezolid, single dose |
|
|
| Moxifloxacin 400 mg | Drug | Oral, 400 mg moxifloxacin, single dose |
|
|
| predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
| Cohort 1: Maximum Observed Plasma Concentration (Cmax) | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
| Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
| Cohort 1: Clearance of Linezolid (CL) | Drug clearance = Dose / AUC inf | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
| Cohort 1: Steady-State Volume of Distribution (Vss) | Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
| Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo | A measure of dispersion is not available. | 0.5, 1, 2, 4, 8, 12, 24 hours post-dose |
| Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo | A measure of dispersion is not available. | 0.5, 1, 2, 4, 8, 12, 24 hours post-dose |
| Cohort 2: AUC Inf and AUC Last | AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
| Cohort 2: Cmax | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
| Cohort 2: Tmax and t1/2 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Tmax is the time to reach Cmax. | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
| Cohort 2: CL | Drug clearance = Dose / AUC inf | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
| Cohort 2: Vss | Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
| Cohort 2: Number of Subjects With AEs and SAEs | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported. | From the time the subject had taken at least one dose of study treatment up to 5 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| Cohort 2: Placebo, Linezolid 600 mg and 1200 mg, Moxifloxacin |
Subjects were randomly assigned to placebo first then moxifloxacin followed by linezolid 600 mg and 1200 mg linezolid last in Sequence 1; or linezolid 600 mg first then linezolid 1200 mg followed by placebo and moxifloxacin last in Sequence 2; or, linezolid 1200 mg first then moxifloxacin 400 mg followed by linezolid 600 mg and placebo last in Sequence 3; or, moxifloxacin 400 mg first then placebo followed by linezolid 1200 mg and 600 mg linezolid last in Sequence 4. There was a washout period of 48 hours between each dose. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Cohort 1: 1200 mg Linezolid | 600 mL Zyvox as a constant rate IV infusion of 60 minutes. |
|
|
| Secondary | Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last) | AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). | PK parameter analysis population | Posted | Mean | Standard Deviation | microgram (ug)*hours (hr)/mL | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
|
|
|
| Secondary | Cohort 1: Maximum Observed Plasma Concentration (Cmax) | PK parameter analysis population | Posted | Mean | Standard Deviation | ug/mL | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
|
|
|
| Secondary | Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | PK parameter analysis population | Posted | Median | Full Range | hr | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
|
|
|
| Secondary | Cohort 1: Clearance of Linezolid (CL) | Drug clearance = Dose / AUC inf | PK parameter analysis population | Posted | Mean | Standard Deviation | mL/minute (min)/kilogram (kg) | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
|
|
|
| Secondary | Cohort 1: Steady-State Volume of Distribution (Vss) | Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL | PK parameter analysis population | Posted | Mean | Standard Deviation | L/kg | predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion |
|
|
|
| Primary | Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo | The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia's formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available. | The pharmacokinetic (PK) parameter analysis population was defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Number | milliseconds (msec) | 0.5, 1, 2, 4, 8, 12, 24 hours post-dose |
|
|
|
|
| Secondary | Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo | A measure of dispersion is not available. | PK parameter analysis population | Posted | Number | msec | 0.5, 1, 2, 4, 8, 12, 24 hours post-dose |
|
|
|
|
| Secondary | Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo | A measure of dispersion is not available. | PK parameter analysis population | Posted | Number | msec | 0.5, 1, 2, 4, 8, 12, 24 hours post-dose |
|
|
|
|
| Secondary | Cohort 2: AUC Inf and AUC Last | AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). | PK parameter analysis population | Posted | Mean | Standard Deviation | ug *hr/mL | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
|
|
|
| Secondary | Cohort 2: Cmax | PK parameter analysis population | Posted | Mean | Standard Deviation | ug/mL | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
|
|
|
| Secondary | Cohort 2: Tmax and t1/2 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Tmax is the time to reach Cmax. | PK parameter analysis population | Posted | Median | Full Range | hr | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
|
|
|
| Secondary | Cohort 2: CL | Drug clearance = Dose / AUC inf | PK parameter analysis population | Posted | Mean | Standard Deviation | mL/min/kg | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
|
|
|
| Secondary | Cohort 2: Vss | Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL | PK parameter analysis population | Posted | Mean | Standard Deviation | L/kg | Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose |
|
|
|
| Secondary | Cohort 2: Number of Subjects With AEs and SAEs | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported. | SAS | Posted | Number | participants | From the time the subject had taken at least one dose of study treatment up to 5 weeks |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Cohort 1: 900 mg Linezolid | 0 | 9 | 3 | 9 |
| EG002 | Cohort 1: 1200 mg Linezolid | 0 | 9 | 2 | 9 |
| EG003 | Cohort 2: Placebo | 0 | 40 | 4 | 40 |
| EG004 | Cohort 2: 600 mg Linezolid | 0 | 40 | 3 | 40 |
| EG005 | Cohort 2: 1200 mg Linezolid | 0 | 40 | 7 | 40 |
| EG006 | Cohort 2: 400 mg Moxifloxacin | 0 | 40 | 10 | 40 |
| Abdominal distension | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hunger | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| 2 hours |
|
| 4 hours |
|
| 8 hours |
|
| 12 hours |
|
| 24 hours |
|
| Mean Difference (Final Values) |
| -2.96 |
| 90 |
| -5.13 |
| -0.79 |
| No |
| Superiority or Other |
| Inferential analysis at 2 hour post-dose | Mean Difference (Final Values) | -5.53 | 90 | -7.70 | -3.36 | No | Superiority or Other |
| Inferential analysis at 4 hour post-dose | Mean Difference (Final Values) | 0.40 | 90 | -1.77 | 2.57 | No | Superiority or Other |
| Inferential analysis at 8 hour post-dose | Mean Difference (Final Values) | -1.37 | 90 | -3.54 | 0.80 | No | Superiority or Other |
| Inferential analysis at 12 hour post-dose | Mean Difference (Final Values) | 1.01 | 90 | -1.16 | 3.18 | No | Superiority or Other |
| Inferential analysis at 24 hour post-dose | Mean Difference (Final Values) | -0.64 | 90 | -2.81 | 1.53 | No | Superiority or Other |
| Inferential analysis at 0.5 hour post-dose | Mean Difference (Final Values) | 2.49 | 90 | 0.32 | 4.66 | No | Superiority or Other |
| Inferential analysis at 1 hour post-dose | Mean Difference (Final Values) | -1.78 | 90 | -3.95 | 0.39 | No | Superiority or Other |
| Inferential analysis at 2 hour post-dose | Mean Difference (Final Values) | -7.51 | 90 | -9.68 | -5.34 | No | Superiority or Other |
| Inferential analysis at 4 hour post-dose | Mean Difference (Final Values) | 3.47 | 90 | 1.30 | 5.64 | No | Superiority or Other |
| Inferential analysis at 8 hour post-dose | Mean Difference (Final Values) | 1.13 | 90 | -1.04 | 3.30 | No | Superiority or Other |
| Inferential analysis at 12 hour post-dose | Mean Difference (Final Values) | 1.47 | 90 | -0.70 | 3.64 | No | Superiority or Other |
| Inferential analysis at 24 hour post-dose | Mean Difference (Final Values) | 1.80 | 90 | -0.37 | 3.97 | No | Superiority or Other |
| 2 hours |
|
| 4 hours |
|
| 8 hours |
|
| 12 hours |
|
| 24 hours |
|
| Mean Difference (Final Values) |
| 6.83 |
| 90 |
| 4.66 |
| 9.00 |
| No |
| Superiority or Other |
| Inferential analysis at 2 hour post-dose | Mean Difference (Final Values) | 10.27 | 90 | 8.10 | 12.44 | No | Superiority or Other |
| Inferential analysis at 4 hour post-dose | Mean Difference (Final Values) | 9.84 | 90 | 7.67 | 12.01 | No | Superiority or Other |
| Inferential analysis at 8 hour post-dose | Mean Difference (Final Values) | 9.40 | 90 | 7.23 | 11.58 | No | Superiority or Other |
| Inferential analysis at 12 hour post-dose | Mean Difference (Final Values) | 7.05 | 90 | 4.87 | 9.22 | No | Superiority or Other |
| Inferential analysis at 24 hour post-dose | Mean Difference (Final Values) | 6.52 | 90 | 4.35 | 8.69 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 2 hours |
|
| 4 hours |
|
| 8 hours |
|
| 12 hours |
|
| 24 hours |
|
| Mean Difference (Final Values) |
| -7.45 |
| 90 |
| -11.51 |
| -3.40 |
| No |
| Superiority or Other |
| Inferential analysis at 2 hour post-dose | Mean Difference (Final Values) | -5.75 | 90 | -9.81 | -1.70 | No | Superiority or Other |
| Inferential analysis at 4 hour post-dose | Mean Difference (Final Values) | -0.92 | 90 | -4.97 | 3.13 | No | Superiority or Other |
| Inferential analysis at 8 hour post-dose | Mean Difference (Final Values) | -5.64 | 90 | -9.69 | -1.58 | No | Superiority or Other |
| Inferential analysis at 12 hour post-dose | Mean Difference (Final Values) | -2.29 | 90 | -6.34 | 1.77 | No | Superiority or Other |
| Inferential analysis at 24 hour post-dose | Mean Difference (Final Values) | -0.59 | 90 | -4.64 | 3.47 | No | Superiority or Other |
| Inferential analysis at 0.5 hour post-dose | Mean Difference (Final Values) | -3.49 | 90 | -7.54 | 0.57 | No | Superiority or Other |
| Inferential analysis at 1 hour post-dose | Mean Difference (Final Values) | -12.19 | 90 | -16.24 | -8.13 | No | Superiority or Other |
| Inferential analysis at 2 hour post-dose | Mean Difference (Final Values) | -14.39 | 90 | -18.44 | -10.33 | No | Superiority or Other |
| Inferential analysis at 4 hour post-dose | Mean Difference (Final Values) | -2.19 | 90 | -6.24 | 1.87 | No | Superiority or Other |
| Inferential analysis at 8 hour post-dose | Mean Difference (Final Values) | 1.10 | 90 | -2.95 | 5.15 | No | Superiority or Other |
| Inferential analysis at 12 hour post-dose | Mean Difference (Final Values) | 0.11 | 90 | -3.94 | 4.17 | No | Superiority or Other |
| Inferential analysis at 24 hour post-dose | Mean Difference (Final Values) | 2.68 | 90 | -1.37 | 6.73 | No | Superiority or Other |
| SAEs |
|