Bioavailability of Aliskiren and Valsartan as a Single Tablet vs. the Same Doses of the Two Drugs Given Separately to Healthy Subjects.
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 150/80 mg Tablets and the Free Combination of Aliskiren 150 mg and Valsartan 80 mg in Healthy Subjects
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 27, 2006
CompletedFirst Posted
Study publicly available on registry
December 28, 2006
CompletedJune 22, 2007
June 1, 2007
December 27, 2006
June 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
To characterize the fixed dose combination of aliskiren/valsartan via PK samples at pre-determined time points.
The safety and tolerability of a single oral dose of a fixed and free combination aliskiren/valsartan.
Interventions
Eligibility Criteria
You may qualify if:
- 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..
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Investigator site
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 27, 2006
First Posted
December 28, 2006
Study Start
November 1, 2006
Last Updated
June 22, 2007
Record last verified: 2007-06