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

NCT00414947 | Completed Phase 1

• 1 other identifier: CLAF237A2111
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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,

Conditions

Healthy

Keywords

Bioequivalence; safety; LAF237; vildagliptin; Chinese; healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. to imported vildagliptin tablet in Chinese healthy subjects

Secondary Outcomes (1)

• Safety and tolerability of vildagliptin tablet after a 50 mg single dose

Interventions

Vildagliptin (LAF237) DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

Beijing, China

Location

MeSH Terms

Interventions

Vildagliptin; 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: December 1, 2006
• Last Updated: June 22, 2007

Record last verified: 2007-06

Locations

CN (1)