Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT01513668
Brief Summary:
The purpose of this study is to compare single-dose oral bioavailability of acetaminophen 650 mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories, USA (subsidiary of Ranbaxy) with Tylenol extended release geltabs (containing acetaminophen 650 mg) of Mc Neil, Consumer \& Specialty Pharmaceuticals, U.S.A in healthy, adult, male human subjects under fed condition.
Detailed Description:
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:
NCT01513668
Study Brief:
Protocol Section:
NCT01513668