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 | Completed Phase 1

• 1 other identifier: 25-VIN-0343
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration Cmax

  Acceptance range for bioequivalence is 80.00%-125.00% for geometric least square mean ratio (T/R) and it's 90% confidence interval for Cmax

  72 hours

• Area Under the Curve from time zero to time of last measurable concentration AUC0-t

  Acceptance range for bioequivalence is 80.00%-125.00% for geometric least square mean ratio (T/R) and it's 90% confidence interval for AUC0-t.

  72 hours

Secondary Outcomes (5)

• Area Under the Curve from time zero to time infinite AUC0-∞

  72 hours

• Time to reach peak plasma concentration Tmax

  72 hours

• Plasma Elimination Half-Life t1/2

  72 hours

• The elimination rate constant associated with the terminal (log-linear) portion of the curve Kel

  72 hours

• AUC0-t/ AUC0-∞

  72 hours

Study Arms (2)

Ertugliflozin/Metformin film coated tablets

EXPERIMENTAL

7.5 mg Ertugliflozin / 1000 mg Metformin

Drug: Ertugliflozin/Metformin film coated tablets; Drug: Segluromet film coated tablets

Segluromet film coated tablets

ACTIVE COMPARATOR

7.5 mg Ertugliflozin / 1000 mg Metformin

Drug: Ertugliflozin/Metformin film coated tablets; Drug: Segluromet film coated tablets

Interventions

Segluromet film coated tablets DRUG

7.5 mg Ertugliflozin/ 1000 mg Metformin

Ertugliflozin/Metformin film coated tablets; Segluromet film coated tablets

Ertugliflozin/Metformin film coated tablets DRUG

1 tablet of 7.5 mg Ertugliflozin / 1000 mg Metformin

Ertugliflozin/Metformin film coated tablets; Segluromet film coated tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject will be selected for study participation, if they meet the following criteria:
• Subjects aged between 18 to 45 years (both inclusive).
• Subjects' weight within normal range according to normal values for Body Mass Index (between 18.5 to 30.0 kg/m2) (both inclusive) with minimum of 45 kg weight.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range \[Annexure III\].
• Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
• Subjects having clinically acceptable chest X-Ray (PA view), if taken.
• Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
• Subjects having negative urine alcohol test / breath alcohol test.
• Non-smoker.
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.
• Subject with Creatinine Clearance ˃45 ml/min.
• For male Subjects:
• Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects willing to refrain from donating sperm during the study period
• For Female Subjects:
• Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence, bilateral tubal ligation or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam

You may not qualify if:

• Subjects will be excluded from the study, if they meet any of the following criteria:
• Hypersensitivity to Ertugliflozin and Metformin or related class of drugs or any of its excipients or heparin.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
• Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
• Presence of alcoholism or drug abuse.
• History or presence of asthma, urticaria or other significant allergic reactions.
• History or presence of significant gastric and/or duodenal ulceration.
• History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
• History or presence of cancer or basal or squamous cell carcinoma.
• Difficulty with donating blood.
• Difficulty in swallowing solids dosage form like tablets or capsules.
• Use of any prescribed medication or OTC medication including vaccines, vitamins and herbal remedies during last 30 days prior to admission in period 01.
• Major illness within past 3 months.
• Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
• Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Veeda Clinical Research Limited

Gujrat, Gujarat, 384205, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ertugliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 5, 2025
• Study Start: August 22, 2025
• Primary Completion: September 4, 2025
• Study Completion: October 11, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

IN (1)