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:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00415883
First received: December 22, 2006
Last updated: June 21, 2007
Last verified: June 2007
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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:
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
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 Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013