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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Valsartan

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Mumbai, India
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Relative bioavailability of valsartan 160 mg Japanese formulation and valsartan 160 mg global formulation under fasting conditions in healthy adult volunteers

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: July 1, 2006

Study Registration Dates

• First Submitted: December 22, 2006
• First Submitted That Met QC Criteria: December 22, 2006
• First Posted (Estimate): December 25, 2006

Study Record Updates

• Last Update Posted (Estimate): June 22, 2007
• Last Update Submitted That Met QC Criteria: June 21, 2007
• Last Verified: June 1, 2007

More Information

Terms related to this study

• Keywords: Relative bioavailability, formulation, Japanese, valsartan, healthy subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: CVNP489A2106