An Open Label, Balanced, Randomized, Three-treatment, Three-period, Six-sequence, Cross-over, Single Dose, Comparative Bioavailability Pilot Study of Two Test Formulations of Fixed Dose Combination Capsules of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Manufactured by Piramal Healthcare Limited, India for GSK Comparing With Aspirin Protect 100 mg Tablets by Bayer Vital GmbH, and Protium 20 mg Gastro-resistant Tablets by Nycomed GmbH, in Healthy, Adult, Human Subjects, Under Fasting Conditions

Trial Profile

An Open Label, Balanced, Randomized, Three-treatment, Three-period, Six-sequence, Cross-over, Single Dose, Comparative Bioavailability Pilot Study of Two Test Formulations of Fixed Dose Combination Capsules of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Manufactured by Piramal Healthcare Limited, India for GSK Comparing With Aspirin Protect 100 mg Tablets by Bayer Vital GmbH, and Protium 20 mg Gastro-resistant Tablets by Nycomed GmbH, in Healthy, Adult, Human Subjects, Under Fasting Conditions

Completed
Phase of Trial: Phase I

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Aspirin/pantoprazole (Primary) ; Aspirin; Pantoprazole
  • Indications Duodenal ulcer; Gastric ulcer
  • Focus Pharmacokinetics
  • Most Recent Events

    • 31 May 2013 Status changed from not yet recruiting to completed as reported by Clinical Trials Registry - India.
    • 31 May 2013 New source identified and integrated (Clinical Trials Registry - India; CTRI2013-06-003713).
    • 10 May 2013 New trial record
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