Safety, Tolerability, Effect of Vildagliptin and How the Body Changes the Blood Level of Vildagliptin in Healthy Chinese Volunteers

NCT ID: NCT00419887

Last Updated: 2007-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30

Brief Summary

The purpose of this study is to assess the safety, tolerability, effect of vildagliptin and how the body changes the blood level of vildagliptin of single and multiple oral doses of vildagliptin in healthy Chinese volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Vildagliptin (LAF237)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chinese healthy volunteers age 18 to 45 years of age included
• In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
• All subjects must have both parents of Chinese origin and citizenship and must have been born in China.
• Body mass index (BMI) within the range of 19 to 24 kg/m2 and weigh at least 50 kg

Exclusion Criteria

• Smokers
• Use of any prescription drugs within four (4) weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two (2) weeks prior to dosing. Paracetamol (or equivalent in China) is acceptable
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
• 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 Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease) Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis) Known hypersensitivity or severe adverse event to darifenacin or similar drugs Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis

Beijing, , China

Countries

China

Other Identifiers

CLAF237A2109

Identifier Type: -

Identifier Source: org_study_id