Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-03 @ 7:15 AM
Study NCT ID:
NCT01847404
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: