Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-01-01 @ 5:06 PM
Study NCT ID:
NCT06124495
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
Sponsor:
Galenicum Health
Organization:
Study Overview
Official Title:
An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg / 500 mg (FDC) of Galenicum Health S.L.U., Spain With That of JANUMET® XR (Sitagliptin Phosphate / Metformin Hydrochloride) Extended-release Coated Tablets 50 mg / 500 mg (FDC) of Merck Sharp & Dohme Pharmaceuticals Ltd., Brasil in Healthy Adult Male and Female Subjects Under Fasting Conditions.
Status:
COMPLETED
Status Verified Date:
2023-11
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:
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose administration under fasting conditions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: