Overview

Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fed Conditions

Status:
Completed

Trial end date:
2013-07-01

Target enrollment:

Participant gender:

Summary

An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over, single dose, comparative bioavailability pilot study under fed conditions. For fed condition, after check-in, subjects will receive a standard dinner consisting (1000 - 1200 calories) after which they will be required to fast overnight (for at least 10 hours). Thereafter they will receive a non-vegetarian high calorie, high-fat breakfast (800-1000 calories) before dosing, and a standard meal (1700 - 1900 calories) for lunch, snacks and dinner.

Phase:

Phase 1

Details

Lead Sponsor:

GlaxoSmithKline

Collaborator:

Piramal Clinical Research (Hyderabad, India)

Treatments:

Aspirin
Pantoprazole