Clinical trial NCT00415883: To Compare the Blood Level of Marketed Japanese Valsartan Tablet Formulation vs Global Valsartan Tablet Formulation in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Relative bioavailability, formulation, Japanese, valsartan, healthy subjects
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Relative bioavailability of valsartan 160 mg Japanese formulation and valsartan 160 mg global formulation under fasting conditions in healthy adult volunteers
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Novartis Investigative Site
Study officials:
affiliation: Investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: