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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414947
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : June 22, 2007
Information provided by:

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 Chinese healthy volunteers.

This trial is not recruiting patients in the United States,

Condition or disease Intervention/treatment Phase
Healthy Drug: Vildagliptin (LAF237) Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Randomized, Open-Label, Crossover, Single Oral Dose Study to Assess the Bioequivalence of LAF237 Tablet Manufactured by Beijing Novartis Pharma Ltd. to Imported LAF237 Tablet in Chinese Healthy Subjects
Study Start Date : December 2006

Primary Outcome Measures :
  1. Rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. to imported vildagliptin tablet in Chinese healthy subjects

Secondary Outcome Measures :
  1. Safety and tolerability of vildagliptin tablet after a 50 mg single dose

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00414947

Novartis Investigative Site
Beijing, China
Sponsors and Collaborators
Principal Investigator: Novartis Investigator site Identifier: NCT00414947     History of Changes
Other Study ID Numbers: CLAF237A2111
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: June 22, 2007
Last Verified: June 2007

Keywords provided by Novartis:
healthy subjects

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs