Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets

NCT07691203 | Completed Phase 1

• 1 other identifier: C1B06324
• Study Type: interventional
• Target: 36
• 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/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) in healthy subject in fed condition.

Conditions

Type 2 Diabetes Mellitus (T2DM); Cardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

• For Empagliflozin & Linagliptin & Metformin; 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

  Empagliflozin & Metformin; 48 hours, Linagliptin; 72 hours

• For Empagliflozin & Metformin; 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

  Empagliflozin & Metformin: 48 hours

• For Linagliptin; Area under the plasma concentration-time curve from 0 to 72 hours (AUC72)

  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

  72 hours

Secondary Outcomes (3)

• For Empagliflozin & Linagliptin & Metformin; Time to reach maximum concentration Cmax (Tmax)

  Empagliflozin & Metformin: 48 hours, Linagliptin: 72 hours

• For Metformin : Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration(AUCt)

  48 hours

• For Empagliflozin: Area under the plasma concentration versus time curve from zero to infinity (AUCi)

  48 hours

Study Arms (2)

Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet

EXPERIMENTAL

Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet

Drug: Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet; Drug: Trijardy® XR Tablets

Trijardy® XR extended-release tablets

ACTIVE COMPARATOR

Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg)

Drug: Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet; Drug: Trijardy® XR Tablets

Interventions

Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet DRUG

1 extended Release tablet of Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg

Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet; Trijardy® XR extended-release tablets

Trijardy® XR Tablets DRUG

1 extended Release tablet of Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg

Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet; Trijardy® XR extended-release tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 55 years old, both inclusive.
• Gender: Male and/or non-pregnant, non-lactating female. A. Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days of the first dose of study medication. They used an acceptable form of contraception.
• For female of child-bearing potential, acceptable forms of contraception included the following:
• i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
• B. Females were not considered of child-bearing potential if one of the following was reported and documented on the medical history:
• i. Postmenopausal with spontaneous amenorrhea for at least 12 consecutive months without other medical explanation, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months.
• to 30.0 kg/m2, both inclusive; BMI values were rounded off to one significant digit after decimal point (e.g. 30.04 rounded down to 30.0, while 18.45 rounded up to 18.5).
• Able to communicate effectively with study personnel.
• Non-alcoholic, non-smoker and non-tobacco user (i.e. had no past history of drinking alcohol, smoking and tobacco consuming for at least one year prior to study).
• Normal or clinically non-significant ECG recording during screening.
• Willing to provide written informed consent to participate in the study.
• All participants were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which included: a) A physical examination (clinical examination) with no clinically significant finding.

You may not qualify if:

• History of allergic responses to Empagliflozin, Linagliptin, Metformin or other related drugs, or any of its formulation ingredients.
• Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female participants)\].
• Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
• History or presence of bronchial asthma.
• Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
• Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
• Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• History or evidence of drug dependence.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• A positive hepatitis screen (included subtypes B \& C).
• A positive test result for HIV antibody.
• Participant who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
• Participant who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or \>200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
• History of difficulty in swallowing or of any gastrointestinal disease, which affected drug absorption.
• Intolerance to venipuncture.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Sarkhej, 382210, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

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 1, 2026
• First Posted: July 8, 2026
• Study Start: March 7, 2026
• Primary Completion: June 16, 2026
• Study Completion: July 1, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

IN (1)