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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00415883 |
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 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study ID Numbers: | CVNP489A2106 |
Study First Received: | December 22, 2006 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00415883 |
Health Authority: | India: Indian Council of Medical Research |
Relative bioavailability, formulation, Japanese, valsartan, healthy subjects |
Healthy Valsartan |
Therapeutic Uses Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |