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Bioequivalence Study to Compare Empagliflozin + Linagliptin 25 mg/5 mg Film-coated Tablets Versus Glyxambi 25 mg/ 5 mg Film-coated Tablets | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Bioequivalence Study to Compare Empagliflozin + Linagliptin 25 mg/5 mg Film-coated Tablets Versus Glyxambi 25 mg/ 5 mg Film-coated Tablets

An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Condition

NCT06932159•Humanis Saglık Anonim Sirketi

View on ClinicalTrials.gov

Summary

An open label, balanced, randomized, single dose, two treatment, two sequence, two period, two way crossover oral bioequivalence study in healthy, adult, human subjects under fasting condition.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion 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 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.
+6 more criteria

Exclusion Criteria

•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.
+11 more criteria

Locations (1)

Veeda Clinical Research Ltd.

Ahmedabad, Gujarat, India

Key Dates

Start Date

December 23, 2024

Primary Completion Date

March 7, 2025

Completion Date

April 8, 2025

Last Updated

April 17, 2025

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

Empagliflozin + Linagliptin film-coated tablets

DRUG

Glyxambi film-coated tablets

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bioequivalence Study to Compare Empagliflozin + Linagliptin 25 mg/5 mg Film-coated Tablets Versus Glyxambi 25 mg/ 5 mg Film-coated Tablets

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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