Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Aliskiren
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects age 18 to 45 years (inclusive) in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiogram, and laboratory tests at screening and baseline.. Female subjects of child bearing potential must be using a double-barrier local contraception i.e. 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). Body mass index (BMI) must be 18 - 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg. Vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure, 90-140 mm Hg, diastolic blood pressure, 50-90 mm Hg, pulse rate, 40 - 90 beats per minute (bpm) Exclusion Criteria: Smokers (use of tobacco products within the previous 3 months). Smokers will be defined who reports tobacco use or has a urine cotinine value of ≥ 300 ng/mL. Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetominophen is acceptable, with supportive clinical documentation.. Participation in any clinical investigation within a minimum of 4 weeks prior to dosing (or longer if local regulations apply). Significant illness within the 2 weeks prior to dosing. Lactating and breast feeding females. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aliskiren|nan|
|Drug: Valsartan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative bioavailability of the fixed dose combination of aliskiren/valsartan versus the free combination of aliskiren and valsartan via PK samples at pre-determined time points from pre-dose to 96 hours post-dose. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the fixed dose combination of aliskiren/valsartan via Pk samples at pre-determines time points. |  |  | 
| The safety and tolerability of a single oral dose of a fixed and free combination aliskiren/valsartan. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aliskiren , Valsartan, bioavailability, hypertension, Healthy male and female subjects