Status:
COMPLETED
Bioequivalence of Vildagliptin Tablet Manufactured in China Compared to Imported Vildagliptin Tablet in Chinese Healthy Volunteers
Lead Sponsor:
Novartis
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
This study will evaluate the bioequivalence as well as rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported vildagliptin tablet in...
Eligibility Criteria
Inclusion
- Chinese healthy male subjects age 18 to 40 years of age included
- In good health
- Male subjects using a double-barrier local contraception for the entire duration of the study up to study completion visit and refraining from fathering a child in the three months following last study drug administration.
- Body mass index within the range of 19 to 24 kg/m2 and weigh at least 50 kg
Exclusion
- Smokers
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.
- Participation in any clinical investigation within 4 weeks prior to dosing.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Significant illness within two weeks prior to dosing.
- A past personal or close family medical history of clinically significant cardiac abnormalities.
- History of:
- Fainting, low blood pressure when standing, irregular heartbeats,
- Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated),
- Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
- Known hypersensitivity to the study drug or similar drugs
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or jeopardize participation in the study.
- Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- Drug or alcohol abuse within the 12 months prior to dosing
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00414947
Start Date
December 1 2006
Last Update
June 22 2007
Active Locations (1)
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1
Novartis Investigative Site
Beijing, China