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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 14, 2013

Primary Completion Date

June 28, 2013

Study Completion Date

June 28, 2013

Conditions

Ulcers, Duodenal and Gastric

Interventions

DRUG

Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one

Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK

DRUG

Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two

Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK

DRUG

ASA 100 mg tablet

Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany

DRUG

Pantoprazole 20 mg gastro-resistant tablet

Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany

Trial Locations (1)

500 013

GSK Investigational Site, Hyderabad