drugset / Trial / NCT01847404

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

NCT01847404

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2013-05-14
Primary completion
2013-06-28
Completion
2013-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 100 mg
Subject Pantoprazole Other / unclassified 20 mg

Indications