Status:
COMPLETED
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.
Lead Sponsor:
AET Laboratories Private Limited
Conditions:
To Determine Bioequivalence Under Fed Conditions
Eligibility:
MALE
18-45 years
Phase:
NA
Brief 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 Pr...
Eligibility Criteria
Inclusion
- 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.
- No history or presence of smoking.
- No history or presence of alcoholism and drug of abuse.
Exclusion
- 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.
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer or basal or squamous cell carcinoma.
- Difficulty with donating blood.
- Difficulty in swallowing solids like tablets or capsules.
- Use of any prescribed medication during the last one month or OTC medication during last two weeks prior to Dosing in Period 01.
- Major illness during 3 months before screening.
- Donation of blood in the past 3 months before screening.
- Participation in drug research study within past 3 months.
- 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.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05329857
Start Date
December 1 2015
End Date
March 1 2016
Last Update
April 15 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.