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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00416468 |
This study will assess the bioavailability of aliskiren and valsartan as a single tablet compared to the same doses of the two drugs given as two separate tablets in healthy subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Aliskiren 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, Two-Treatment, Two Period Crossover, Single-Dose Study to Determine the Relative Bioavailability of Fixed Combination of Final Market Image (FMI) Aliskiren/Valsartan 75/160 mg Tablets and the Free Combination of Aliskiren 75 mg and Valsartan 160 mg in Healthy Subjects |
Estimated Enrollment: | 32 |
Study Start Date: | November 2006 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
intra-uterine device plus condom, or spermicidal gel plus condom for at least 3 months prior to Study start or postmenopausal females must have had no regular menstrual bleeding for at least 1 year prior to inclusion (Menopause will be confirmed by a plasma FSH level of >40 IU/L) or female subjects must have been surgically sterilized at least 6 months prior to screening with supportive clinical documentation. and all female subjects must have negative pregnancy results at screening and each baseline (regardless of reported reproductive status).
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study ID Numbers: | CSPV100A2101 |
Study First Received: | December 27, 2006 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00416468 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Aliskiren , Valsartan, bioavailability, hypertension Healthy male and female subjects |
Cardiovascular Agents Healthy Antihypertensive Agents Valsartan Hypertension |
Therapeutic Uses Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Valsartan |