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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00416468
First received: December 27, 2006
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Aliskiren
Drug: Valsartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Estimated Enrollment: 32
Study Start Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416468

Locations
United States, New Jersey
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00416468     History of Changes
Other Study ID Numbers: CSPV100A2101
Study First Received: December 27, 2006
Last Updated: June 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Aliskiren , Valsartan, bioavailability, hypertension
Healthy male and female subjects

Additional relevant MeSH terms:
Valsartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014