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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT01064232
Brief Summary:
A Single-dose, Randomized, two-Period, Cross over Study
Detailed Description:
Randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1 mg risperidone tablets under fasting conditions.
The test formulation was Dr. Reddy's Laboratories Limited's Risperidone Tablets, 1 mg, and the reference formulation was Risperdal® (risperidone) tablets, 1 mg (Janssen Pharmaceutica Products, L.P.).
The study was conducted with 30 healthy adults. In each study period, a single 1 mg dose was administered to all subjects following an overnight fast.The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
Study:
NCT01064232
Study Brief:
Protocol Section:
NCT01064232