Who is sponsoring NCT01603134?

NCT01603134 is sponsored by IPCA Laboratories Ltd..

What condition does NCT01603134 study?

NCT01603134 studies Fasting State.

What drugs are being tested in NCT01603134?

Interventions: Allopurinol, Allopurinol.

What is the status of NCT01603134?

NCT01603134 is currently COMPLETED.

Last reviewed 2012-05-21 · How we verify

A Randomized, Open Label, Two-Period, Two-Treatment, Two-Sequence, Single Dose, Crossover Comparative Bioequivalence Study of Allopurinol 300 mg Tablets USP With Zyloprim® 300 mg in Normal, Healthy, Adult, Human Male Subjects Under Fasting Condition.

NCT01603134 Phase 1 COMPLETED

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human male subjects.

Details

Lead sponsor	IPCA Laboratories Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2007-11
Completion	2008-04

Conditions

Fasting State

Interventions

Allopurinol
Allopurinol

Primary outcomes

Bioequivalence is based on Cmax and AUC parameters. — 6 months
Area Under Curve (AUC) and Cmax Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00 and 96.00 hours post-dose.

Countries

India