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.

To Determine Bioequivalence Under Fed Conditions Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05329857
• Other study ID #: 14-VIN-410
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2022
• Source: Alfred E. Tiefenbacher (GmbH & Co. KG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate and compare the relative bioavailability and therefore the bioequivalence of 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Malnutrition
• To Determine Bioequivalence Under Fed Conditions

Intervention

Drug:
• Metformin and Vildagliptin 1000/50 mg
50 mg Vildagliptin + 1000 mg Metformin as single-dose per study period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AET Laboratories Private Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	AUC0-8 of Vildagliptin and Metformin for the test and the reference products	The area under the plasma concentration versus time curve from time 0 to to infinite time	up to 24 hours
Secondary	Tmax of Vildagliptin and Metformin for the test and the reference products	The time to maximum measured plasma concentration	up to 24 hours
Secondary	T1/2 of Vildagliptin and Metfomin for the test and the reference products	Plasma elimination half-life	up to 24 hours
Secondary	Kel of Vildagliptin and Metformin for the test and the reference products	Elimination rate constant	up to 24 hours
Secondary	Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol	An AE is defined as any untoward medical occurrence in a subject administered the test or the reference product and which does not necessarily have a causal relationship with the treatment.	through study completion, an average of 1 month