A Relative Bioavailability Study of Acetaminophen Extended Release Gel Tabs 650 mg Under Fasting Condition
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|ClinicalTrials.gov Identifier: NCT01523080|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Acetaminophen||Not Applicable|
The study was conducted as 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 Inc. (subsidiary of Ranbaxy) with Tylenol 8 hour extended release gel tabs (containing acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals in healthy, adult, human, male subjects under fasting 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 after an overnight fast of at least 10 hours under supervision of a trained study personnel.
During the course of the study, safety parameters inclusive of vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) at base line were assessed. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 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 Inc. (Subsidiary of Ranbaxy) With Tylenol 8 Hour Extended Release Gel Tabs (Containing Acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals in Healthy, Adult, Human, Male Subjects Under Fasting Condition|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||July 2006|
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
Experimental: Acetaminophen extended release Gel tabs 650 mg
Acetaminophen extended release Gel tabs 650 mg of OHM Laboratories Inc. (A subsidiary of Ranbaxy Pharmaceuticals Inc., 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, 0.167, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16 and 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): NCT01523080
|Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)|
|New Delhi, India, 110 062|