Diabetes Mellitus
Conditions
Brief summary
To evaluate and compare the relative bioavailability and therefore the bioequivalence of Vildagliptin Tablets 50 mg of AET Laboratories Private Limited, India, with GALVUS® 50 mg Tablets of Novartis Europharm Limited, United Kingdom, in normal, healthy, adult, male human subjects under fasting conditions and to evaluate the safety and tolerability of Vildagliptin Tablets 50 mg in normal, healthy, adult, male human subjects under fasting conditions.
Interventions
50 mg Vildagliptin as single-dose per study period
Sponsors
AET Laboratories Private Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 (18.5 to 30 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. 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 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. 8. Difficulty with donating blood. 9. Difficulty in swallowing solids like tablets or capsules. 10. Use of any prescribed or OTC medication during last two weeks prior to Dosing in Period 01. 11. Major illness during 3 months before screening. 12. Participation in a drug research study within past 3 months. 13. Donation of blood in the past 3 months before screening. 14. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C. 15. History or presence of significant easy bruising or bleeding. 16. History or presence of significant recent trauma. 17. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of Vildagliptin for the test and reference products | up to 24 hours | The maximum concentration in plasma among observed concentrations at pre-specified time points |
| AUC0-t of Vildagliptin for the test and the reference products | up to 24 hours | The area under the plasma concentration versus time curve from time 0 to the last measured concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T1/2 of Vildagliptin for the test and the reference products | up to 24 hours | Plasma elimination half-life |
| AUC0-∞ of Vildagliptin for the test and the reference products | up to 24 hours | The area under the plasma concentration versus time curve from time 0 to to infinite time |
| 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 | 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. |
| Kel of Vildagliptin for the test and the reference products | up to 24 hours | Elimination rate constant |
| Tmax of Vildagliptin for the test and the reference products | up to 24 hours | The time to maximum measured plasma concentration |
Outcome results
None listed