Bioequivalence Study to Compare Empagliflozin/ Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg

NCT07694115 | Completed Phase 1

• 1 other identifier: 26-VIN-0091
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets 25mg/1000mg in healthy subject in fasting condition.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (2)

• Maximum concentration obtained (Cmax)

  two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data Cmax

  48 hours

• AUC from time 0 to last collection time (AUC0 - t)

  two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data AUC

  48 hours

Secondary Outcomes (2)

• Time to reach maximum concentration Cmax (Tmax)

  48 hours

• Area under the plasma concentration versus time curve from time 0 to 24 hour (AUC0-24)

  48 hours

Study Arms (2)

Empagliflozin / Metformin Extended-Release Tablet

EXPERIMENTAL

Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet

Drug: Empagliflozin / Metformin Extended-Release Tablet; Drug: Synjardy XR tablets

Synjardy XR tablets

ACTIVE COMPARATOR

Synjardy XR tablets 25mg/1000mg

Drug: Empagliflozin / Metformin Extended-Release Tablet; Drug: Synjardy XR tablets

Interventions

Empagliflozin / Metformin Extended-Release Tablet DRUG

1 extended Release tablet of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet

Empagliflozin / Metformin Extended-Release Tablet; Synjardy XR tablets

Synjardy XR tablets DRUG

1 extended Release tablet of Synjardy XR tablets 25mg/1000mg

Empagliflozin / Metformin Extended-Release Tablet; Synjardy XR tablets

Eligibility Criteria

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

You may qualify if:

• Participants aged between 18 to 45 years (both inclusive).
• Participants' 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.
• Participants with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range \[Annexure III\].
• Participants having clinically acceptable 12-lead electrocardiogram (ECG).
• Participants having clinically acceptable chest X-Ray (PA view), if taken.
• Participants having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Participants having negative urine alcohol test / breath alcohol test.
• Non-smoker.
• Participants willing to adhere to the protocol requirements and to provide written informed consent.
• Participant with Creatinine Clearance ˃60 ml/min.
• For male Participants: Participants 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. Participants willing to refrain from donating sperm during the study period
• For Female Participants: 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. Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above
• Participants having negative urine pregnancy test at screening and negative serum beta-hCG pregnancy test on admission day of period 01 (only for female participants).

You may not qualify if:

• Hypersensitivity to Empagliflozin 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.
• Participant 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.
• Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Veeda Clinical Research Ltd.

Ahmedabad, Ambawadi, 380 015, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

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

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: July 3, 2026
• First Posted: July 9, 2026
• Study Start: May 7, 2026
• Primary Completion: June 29, 2026
• Study Completion: July 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

IN (1)