The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in … (NCT05337969) | Clinical Trial Compass
CompletedNot Applicable
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.
60 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Cmax of Vildagliptin and Metformin for the test and reference products
Timeframe: up to 24 hours
2
AUC0-t of Vildagliptin and Metformin for the test and the reference products