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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00414947
First received: December 21, 2006
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

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 Intervention Phase
Healthy
Drug: Vildagliptin (LAF237)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • Safety and tolerability of vildagliptin tablet after a 50 mg single dose

Estimated Enrollment: 30
Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414947

Locations
China
Novartis Investigative Site
Beijing, China
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00414947     History of Changes
Other Study ID Numbers: CLAF237A2111
Study First Received: December 21, 2006
Last Updated: June 21, 2007
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Bioequivalence
safety
LAF237
vildagliptin
Chinese
healthy subjects

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

ClinicalTrials.gov processed this record on July 22, 2014