NCT07266779

Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Product (R) of Segluromet 7.5 mg/ 1000 mg Film Coated Tablets in Healthy, Adult, Human Subjects Under Fed Condition.

An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Oral Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets of Humanis Sağlık A.Ş., Ç.O.S.B. Karaağaç Mahallesi Fatih Bulvarı No:32 Kapaklı/TEKİRDAĞ and Reference Product (R) of Segluromet 7.5 mg/ 1000 mg Film Coated Tablets of Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands, in Healthy, Adult, Human Subjects Under Fed Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, Two way crossover, Oral Bioequivalence Study of test product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg film coated tablets of Humanis Sağlık A.Ş., Ç.O.S.B. Karaağaç Mahallesi Fatih Bulvarı No:32 Kapaklı/TEKİRDAĞ and Reference product (R) of Segluromet 7.5 mg/ 1000 mg film coated tablets of Merck Sharp \& Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands, in Healthy, adult, human Subjects Under fed Condition.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Ertugliflozin/Metformin film coated tablets	1 tablet of 7.5 mg Ertugliflozin / 1000 mg Metformin
DRUG	Segluromet film coated tablets	7.5 mg Ertugliflozin/ 1000 mg Metformin

Timeline

• Start date: 2025-08-22
• Primary completion: 2025-09-04
• Completion: 2025-10-11
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: India