Bioequivalence of Vildagliptin Tablet Manufactured in China Compared to Imported Vildagliptin Tablet in Chinese Healthy Volunteers

Inclusion Criteria:

• 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 Criteria:

• 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