Bioavailability of Aliskiren and Valsartan as a Single Tablet vs. the Same Doses of the Two Drugs Given Separately to Healthy Subjects.

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Valsartan

Drug: Aliskiren

Study type

Interventional

Funder types

Industry

Identifiers

NCT00416728

CSPV100A2102

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects 18 to 45 years (inclusive) of age 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