The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 1000/50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/1000 mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.
Sponsor: AET Laboratories Private Limited
This NA trial investigates To Determine Bioequivalence Under Fed Conditions and is currently completed. AET Laboratories Private Limited leads this study, which shows 3 recorded versions since 2015 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
3 versions recorded-
Sep 2024 — Present [monthly]
Completed NA
-
Jul 2024 — Sep 2024 [monthly]
Completed NA
-
May 2022 — Jul 2024 [monthly]
Completed NA
First recorded
Dec 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- AET Laboratories Private Limited
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.