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.

NCT ID: NCT05337969

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Metformin and Vildagliptin 850/50 mg Tablet

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

Group Type: EXPERIMENTAL

Metformin and Vildagliptin 850/50 mg

Intervention Type: DRUG

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

EUCREAS® 50/850mg Tablet

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

Group Type: ACTIVE_COMPARATOR

Metformin and Vildagliptin 850/50 mg

Intervention Type: DRUG

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

Interventions

Metformin and Vildagliptin 850/50 mg

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male subjects aged between 18 and 45 years (both inclusive).

2. 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.

3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.

4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).

5. Subjects having clinically acceptable chest X-Ray (PA view).

6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).

7. Subjects having negative alcohol breath test.

8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

9. No history or presence of smoking.

10. No history or presence of alcoholism and drug of abuse.

Exclusion Criteria

1. Hypersensitivity to Vildagliptin or Metformin or related class of drugs.

2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.

3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.

4. History or presence of asthma, urticaria or other significant allergic reactions.

5. History or presence of significant gastric and/or duodenal ulceration.

6. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.

7. History or presence of cancer or basal or squamous cell carcinoma.

8. Difficulty with donating blood.

9. Difficulty in swallowing solids like tablets or capsules.

10. Use of any prescribed medication during the last one month or OTC medication during last two weeks prior to Dosing in Period 01.

11. Major illness during 3 months before screening.

12. Donation of blood in the past 3 months before screening.

13. Participation in drug research study within past 3 months.

14. 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.

15. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.

16. History or presence of significant easy bruising or bleeding.

17. History or presence of significant recent trauma.

18. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AET Laboratories Private Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

15-VIN-692

Identifier Type: -

Identifier Source: org_study_id