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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00415883

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study
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:

Drug Information available for: Valsartan

U.S. FDA Resources

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

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

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

Keywords provided by Novartis:

Relative bioavailability, formulation, Japanese, valsartan, healthy subjects

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Valsartan

ClinicalTrials.gov processed this record on November 09, 2009