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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-07-13

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Piramal Clinical Research (Hyderabad, India)

    collaborator UNKNOWN

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847404 on ClinicalTrials.gov