To Compare and Evaluate the Oral Bioavailability of Empagliflozin + Linagliptin 10 mg/5 mg Filmcoated Tablets With That of Glyxambi 10 mg/ 5 mg Film-coated Tablets in Healthy, Adult, Human Subjects Under Fasting Conditions.

NCT07039890 | Completed Phase 1

• 1 other identifier: 24-VIN-0556
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To compare and evaluate the oral bioavailability of Empagliflozin + Linagliptin 10 mg/5 mg film-coated tablets with that of Glyxambi 10 mg/ 5 mg film-coated tablets in healthy, adult, human subjects under fasting conditions.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (4)

• Peak Plasma Concentration (Cmax)

  For Empagliflozin: 80.00%-125.00% for geometric least square mean ratio (T/R) and it's 90% confidence intervals for Cmax

  72 hours

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

  For Empagliflozin: 80.00%-125.00% for geometric least square mean ratio (T/R) and it's 90% confidence intervals for AUC0-t

  72 hours

• Peak Plasma Concentration (Cmax)

  For Linagliptin: 80.00%-125.00% for geometric least square mean ratio (T/R) and it's 90% confidence intervals for Cmax

  72 hours

• Area Under the Curve from time zero to time of last measurable concentration (AUC0-72)

  For Linagliptin: 80.00%-125.00% for geometric least square mean ratio (T/R) and it's 90% confidence intervals for AUC0-72

  72 hours

Secondary Outcomes (3)

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

  72 hours

• Time to reach peak plasma concentration (Tmax)

  72 hours

• Time to reach peak plasma concentration (Tmax)

  72 hours

Study Arms (2)

Empagliflozin + Linagliptin filmcoated tablets

EXPERIMENTAL

Empagliflozin + Linagliptin 10 mg/5 mg filmcoated tablets

Drug: Empagliflozin + Linagliptin filmcoated tablets; Drug: Glyxambi film-coated tablets

Glyxambi film-coated tablets

ACTIVE COMPARATOR

Glyxambi 10 mg/5 mg film-coated tablets

Drug: Empagliflozin + Linagliptin filmcoated tablets; Drug: Glyxambi film-coated tablets

Interventions

Empagliflozin + Linagliptin filmcoated tablets DRUG

Empagliflozin + Linagliptin 10 mg/5 mg filmcoated tablets

Empagliflozin + Linagliptin filmcoated tablets; Glyxambi film-coated tablets

Glyxambi film-coated tablets DRUG

Glyxambi 10 mg/5 mg film-coated tablets

Empagliflozin + Linagliptin filmcoated tablets; Glyxambi film-coated tablets

Eligibility Criteria

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

You may qualify if:

• 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 the clinically acceptable range.
• Subject with Creatinine Clearance ≥80 ml/min.
• 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.
• 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
• Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above

You may not qualify if:

• Hypersensitivity to Empagliflozin \& Linagliptin 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.
• History or presence of alcoholism or drug abuse.
• History of any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
• 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 Ltd.

Ahmedabad, Gujarat, 382210, 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: June 18, 2025
• First Posted: June 26, 2025
• Study Start: March 8, 2025
• Primary Completion: May 14, 2025
• Study Completion: June 5, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

IN (1)