GSK-APP116480

Study Sponsor: GSK

Study Title

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

Medicine or Vaccine (generic name)

acetylsalicylic acid/pantoprazole

Sponsor Identification Number

APP116480

Trial Registry Identification Number(#'s)

NCT01847404

Medical Condition

Ulcers, Duodenal and Gastric

Phase

Phase 1

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=116480

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT01847404

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

An analysis-ready dataset is not available for this study. An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

May 2017