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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Aliskiren (Drug); Valsartan (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Investigator site


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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:

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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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

Locations and Contacts

Novartis Investigative Site, East Hanover, New Jersey 07936-1080, United States
Additional Information

Starting date: November 2006
Last updated: June 21, 2007

Page last updated: August 23, 2015

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