The Study Intends 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 Evaluated.

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2022
• Main ID: NCT05329857
• Date of registration: 25/03/2022
• Prospective Registration: No
• Primary sponsor: AET Laboratories Private Limited
• Public title: The Study Intends 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 Evaluated.
• Scientific title: Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 1000/50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/1000 mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.
• Date of first enrolment: December 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05329857
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

To Determine Bioequivalence Under Fed Conditions

Intervention(s)

Drug: Metformin and Vildagliptin 1000/50 mg

Primary Outcome(s)

AUC0-t of Vildagliptin and Metformin for the test and the reference products [Time Frame: up to 24 hours]

Cmax of Vildagliptin and Metformin for the test and reference products [Time Frame: up to 24 hours]

Secondary Outcome(s)

Tmax of Vildagliptin and Metformin for the test and the reference products [Time Frame: up to 24 hours]

AUC0-8 of Vildagliptin and Metformin for the test and the reference products [Time Frame: up to 24 hours]

T1/2 of Vildagliptin and Metfomin for the test and the reference products [Time Frame: 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 [Time Frame: through study completion, an average of 1 month]

Kel of Vildagliptin and Metformin for the test and the reference products [Time Frame: up to 24 hours]

Secondary ID(s)

14-VIN-410

Source(s) of Monetary Support

Please refer to primary and secondary sponsors