Overview

Bioequivalence of An Oral Mercaptopurine Suspension 100 Mg / 5 Ml Versus Tablet in Healthy Male Subjects Under Fasting Conditions

Status:
Completed

Trial end date:
2012-11-01

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to determine whether the test product, mercaptopurine oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are bioequivalent. For this purpose the PK profile of 6-mercaptopurine (6-MP) will be compared after administration of a single dose of each of the two formulations, under fasting conditions. The secondary objective is to assess the safety and tolerability of the test product, mercaptopurine oral 100 mg/5 mL suspension.

Phase:

Phase 1

Details

Lead Sponsor:

Nova Laboratories Limited

Treatments:

6-Mercaptopurine
Mercaptopurine