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

Tracking Information

First Received Date ^ICMJE

December 27, 2006

Last Updated Date

June 21, 2007

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00416468 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Aliskiren
Drug: Valsartan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00416468

Responsible Party

Study ID Numbers ^ICMJE

CSPV100A2101

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Novartis

Investigator site

Information Provided By

Novartis

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP