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

NCT05337969 | Completed

• 1 other identifier: 15-VIN-692
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 850/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/850mg tablets manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects under Fed Conditions.

Conditions

To Determine Bioequivalence Under Fed Conditions

Outcome Measures

Primary Outcomes (2)

• Cmax of Vildagliptin and Metformin 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 and Metformin 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 and Metformin for the test and the reference products

  up to 24 hours

• Tmax of Vildagliptin and Metformin for the test and the reference products

  up to 24 hours

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

  up to 24 hours

• Kel of Vildagliptin and Metformin 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)

Metformin and Vildagliptin 850/50 mg Tablet

EXPERIMENTAL

1 tablet of Metformin and Vildagliptin 850/50 mg as single-dose administration

Drug: Metformin and Vildagliptin 850/50 mg

EUCREAS® 50/850mg Tablet

ACTIVE COMPARATOR

1 tablet of EUCREAS® 50/850mg (each film-coated tablet contains Vildagliptin 50mg and Metformin hydrochloride 850mg) as single-dose administration

Drug: Metformin and Vildagliptin 850/50 mg

Interventions

Metformin and Vildagliptin 850/50 mg DRUG

50 mg Vildagliptin + 850 mg Metformin as single-dose per study period

EUCREAS® 50/850mg Tablet; Metformin and Vildagliptin 850/50 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 (18.50 to 30.00 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 (PA view).
• 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 Metformin 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 or basal or squamous cell carcinoma.
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Use of any prescribed medication during the last one month or OTC medication during last two weeks prior to Dosing in Period 01.
• Major illness during 3 months before screening.
• Donation of blood in the past 3 months before screening.
• Participation in drug research study within past 3 months.
• Consumption of grapefruit juice within 72.00 hours prior to dosing in Period 01 and xanthine-containing products, tobacco containing products or alcohol within 48.00 hours prior to dosing in Period 01.
• Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.

Sponsors & Collaborators

• AET Laboratories Private Limited: lead

MeSH Terms

Interventions

Metformin; Vildagliptin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; 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 20, 2022
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 20, 2022

Record last verified: 2022-04