To Compare the Blood Level of Marketed Japanese Valsartan Tablet Formulation vs Global Valsartan Tablet Formulation in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00415883
First received: December 22, 2006
Last updated: June 21, 2007
Last verified: June 2007

December 22, 2006
June 21, 2007
July 2006
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Relative bioavailability of valsartan 160 mg Japanese formulation and valsartan 160 mg global formulation under fasting conditions in healthy adult volunteers
Same as current
Complete list of historical versions of study NCT00415883 on ClinicalTrials.gov Archive Site
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To Compare the Blood Level of Marketed Japanese Valsartan Tablet Formulation vs Global Valsartan Tablet Formulation in Healthy Volunteers
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

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.

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Valsartan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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

Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00415883
CVNP489A2106
No
Not Provided
Novartis
Not Provided
Principal Investigator: Novartis Investigator site
Novartis
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP