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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Valsartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Relative bioavailability of valsartan 160 mg Japanese formulation and valsartan 160 mg global formulation under fasting conditions in healthy adult volunteers

Estimated Enrollment: 40
Study Start Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  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: NCT00415883

Locations
India
Novartis Investigative Site
Mumbai, India
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00415883     History of Changes
Other Study ID Numbers: CVNP489A2106
Study First Received: December 22, 2006
Last Updated: June 21, 2007
Health Authority: India: Indian Council of Medical Research

Keywords provided by Novartis:
Relative bioavailability, formulation, Japanese, valsartan, healthy subjects

Additional relevant MeSH terms:
Valsartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014