The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safeyt Profile of Test Product Compared to Reference Product Will be Assessed.

NCT05329844 | Completed

• 1 other identifier: 13-VIN-343
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate and compare the relative bioavailability and therefore the bioequivalence of Vildagliptin Tablets 50 mg of AET Laboratories Private Limited, India, with GALVUS® 50 mg Tablets of Novartis Europharm Limited, United Kingdom, in normal, healthy, adult, male human subjects under fasting conditions and to evaluate the safety and tolerability of Vildagliptin Tablets 50 mg in normal, healthy, adult, male human subjects under fasting conditions.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Cmax of Vildagliptin for the test and reference products

  The maximum concentration in plasma among observed concentrations at pre-specified time points

  up to 24 hours

• AUC0-t of Vildagliptin for the test and the reference products

  The area under the plasma concentration versus time curve from time 0 to the last measured concentration

  up to 24 hours

Secondary Outcomes (5)

• AUC0-∞ of Vildagliptin for the test and the reference products

  up to 24 hours

• Tmax of Vildagliptin for the test and the reference products

  up to 24 hours

• T1/2 of Vildagliptin for the test and the reference products

  up to 24 hours

• Kel of Vildagliptin for the test and the reference products

  up to 24 hours

• Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol

  through study completion, an average of 1 month

Study Arms (2)

Vildagliptin 50 mg Tablet

EXPERIMENTAL

1 tablet of Vildagliptin 50 mg as single-dose administration

Drug: Vildagliptin 50 MG

Galvus 50 mg Tablet

ACTIVE COMPARATOR

1 tablet of Galvus 50 mg (each tablet contains 50 mg Vildagliptin) as single-dose administration

Drug: Vildagliptin 50 MG

Interventions

Vildagliptin 50 MG DRUG

50 mg Vildagliptin as single-dose per study period

Galvus 50 mg Tablet; Vildagliptin 50 mg Tablet

Eligibility Criteria

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

You may qualify if:

• Male subjects aged between 18 and 45 years (both inclusive).
• Subjects' weight within the normal range according to normal values for the Body Mass Index (18.5 to 30 kg/m2) with minimum of 50 kg weight.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
• Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
• Subjects having clinically acceptable chest X-Ray.
• Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
• Subjects having negative alcohol breath test.
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.
• No history or presence of smoking.
• No history or presence of alcoholism and drug of abuse.

You may not qualify if:

• Hypersensitivity to Vildagliptin or related class of drugs.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
• 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.
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Use of any prescribed or OTC medication during last two weeks prior to Dosing in Period 01.
• Major illness during 3 months before screening.
• Participation in a drug research study within past 3 months.
• Donation of blood in the past 3 months before screening.
• Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
• History or presence of significant easy bruising or bleeding.

Sponsors & Collaborators

• AET Laboratories Private Limited: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 15, 2022
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 15, 2022

Record last verified: 2022-04