Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 6:47 PM
Study NCT ID:
NCT02962258
Status:
COMPLETED
Last Update Posted:
2016-11-11
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed Conditions
Sponsor:
Torrent Pharmaceuticals Limited
Organization:
Study Overview
Official Title:
An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of FDC of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab 40+10+25 mg [Torrent,India] Vs Tribenzor 40+10+25 mg Tablets [ Daichi,USA] in Healthy Subjects-Fed Condition.
Status:
COMPLETED
Status Verified Date:
2016-11
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:
Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.
Detailed Description:
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Tribenzor® 40+10+25 mg Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg (Reference , Daichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed Condition.
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?: