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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00416468
• Date of registration: 27/12/2006
• Primary sponsor: Novartis
• Public title: Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects.
• Scientific 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
• Date of first enrolment: November 2006
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00416468
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Novartis
• Affiliation: Investigator site

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Aliskiren

Drug: Valsartan

Primary Outcome(s)

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(s)

The safety and tolerability of a single oral dose of a fixed and free combination aliskiren/valsartan.

To characterize the fixed dose combination of aliskiren/valsartan via Pk samples at pre-determines time points.

Secondary ID(s)

CSPV100A2101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors