Clinical trial
Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 850/ 50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/850mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.
NCT05337969 is registered in ClinicalTrials.gov with AET Laboratories Private Limited as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 850/ 50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/850mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.
- Lead sponsor
- AET Laboratories Private Limited
- Phase
- Not applicable
- Overall status
- Completed
- Start date
- December 31, 2015
- Completion date
- March 31, 2016
- Enrollment
- 60 (actual)
- Sites
- Not reported
Conditions
As the registry lists them; a condition with its own page is linked.
to determine bioequivalence under fed conditions