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

NCT ID: NCT00416468

Last Updated: 2007-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Aliskiren

Intervention Type: DRUG

Valsartan

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative Site

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CSPV100A2101

Identifier Type: -

Identifier Source: org_study_id