A Relative Bioavailability Study of Acetaminophen Extended Release Gel Tabs 650 mg Under Fed Condition
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|ClinicalTrials.gov Identifier: NCT01513668|
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : January 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Acetaminophen||Not Applicable|
The study was conducted as open label, balanced, randomised, two-treatment, two-period, two-sequence, single dose, crossover bioavailability study comparing acetaminophen 650 mg extended release gel tabs (containing acetaminophen 650 mg) of OHM Laboratories (subsidiary of Ranbaxy) with Tylenol 8 Hour 650 mg extended release gel tabs (containing acetaminophen 650 mg) of Mc Neil, Consumer & Specialty Pharmaceuticals in healthy, adult, human, male subjects under fed condition.
The treatments were assigned to the study subjects according to SAS generated randomization schedule. Each subject received a single oral dose either Test or Reference product in each period with 240ml of water at ambient temperature, 30 minutes after start of a high-fat high calorie breakfast during each period of the study under supervision of a trained medical officer.
During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and clinical laboratory safety tests (hematology & biochemical parameters) were performed again at the end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioavailability Study Comparing Acetaminophen 650 mg Extended Release Gel Tabs (Containing Acetaminophen 650 mg) of OHM Laboratories (Subsidiary of Ranbaxy) With Tylenol 8 Hour 650 mg Gel Tabs (Containing Acetaminophen 650 mg) of Mc Neil, Consumer & Speciality Pharmaceuticals in Healthy, Adult, Human, Male Subjects Under Fed Condition|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||July 2006|
Experimental: Acetaminophen extended release Gel tabs
Acetaminophen extended release Gel tabs 650 mg of OHM Laboratories Inc. (A subsidiary of Ranbaxy Pharmaceuticals Inc., USA)
Extended release Gel tabs 650 mg
Active Comparator: Tylenol® 650 mg
Tylenol® 650 mg of McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, INC. Fort Washington, PA 19034 USA
Extended release Gel tabs 650 mg
- Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Acetaminophen [ Time Frame: 0 to 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513668
|Clinical Pharmacology Unit, B-22, Sector 62|
|Noida, Uttar Pradesh, India, 201 301|