To Compare the Blood Level of Marketed Japanese Valsartan Tablet Formulation vs Global Valsartan Tablet Formulation in Healthy Volunteers
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Valsartan (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Investigator site
Summary
The purpose of this study is to assess how the body changes the blood level of single dose of
valsartan 160 mg tablet Japanese formulation and valsartan 160 mg tablet global formulation
under fasting condition in healthy volunteers.
Clinical Details
Official title: An Open-Label, Randomized, Single Dose, Two Period, Crossover Study to Determine the Relative Bioavailability of Valsartan 160 mg Japanese Formulation and Valsartan 160 mg Global Formulation in Healthy Adult Volunteers
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study
Primary outcome: Relative bioavailability of valsartan 160 mg Japanese formulation and valsartan 160 mg global formulation under fasting conditions in healthy adult volunteers
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy, male or female subjects age 18 to 45 years of age (inclusive)
- In good health
- Female subjects either surgically sterilized at least 6 months prior to study
participation or post-menopausal (no regular menstrual bleeding for at least 2 years)
- Body mass index within the range of 18. 5 to 28 kg/m2 and weigh at least 45 kg
Exclusion Criteria:
- Smokers
- Use prescription drugs within 4 weeks prior dosing, or over-the-counter medication
(vitamins, herbal supplements, dietary supplements, potassium 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
- Significant illness within 2 weeks prior to dosing.
- History of clinically significant cardiac abnormalities, fainting, low blood pressure
upon standing, irregular heartbeats.
- History of acute or chronic bronchospastic disease (including asthma and chronic
obstructive pulmonary disease, treated or untreated).
- History of clinically significant drug allergy or history of atopic allergy (asthma,
urticaria, eczematous dermatitis).
- Known hypersensitivity or severe reaction to valsartan or similar drugs
- Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism or excretion of drugs or which may jeopardize the subject in
case of participation in the study.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western
blot) test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within the 6 months prior to dosing
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Investigative Site, Mumbai, India
Additional Information
Starting date: July 2006
Last updated: June 21, 2007
|
