Overview

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

Status:
Completed

Trial end date:
2013-06-28

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 fasting conditions. The treatments will be administered after an overnight fasting of at least 10 hours in each period. Fasting will continue for four hours post-dose, and then meals will be provided at specified intervals. Drinking water will not be permitted one hour before dosing and until one hour post-dose.

Phase:

Phase 1

Details

Lead Sponsor:

GlaxoSmithKline

Collaborator:

Piramal Clinical Research (Hyderabad, India)

Treatments:

Aspirin
Pantoprazole