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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.

NCT07266779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-22
Primary Completion
2025-09-04
Completion
2025-10-11

Countries

  • India

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266779 on ClinicalTrials.gov