HealthyPhase 1NCT00416468
Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects.
A Phase 1 study testing Aliskiren and Valsartan in people with Healthy, run by Novartis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aliskiren and Valsartan
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
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
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
- Being tested
- Aliskiren, Valsartan
- Keywords
- Aliskiren , Valsartan, bioavailability, hypertension, Healthy male and female subjects
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
ValsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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-determines time points.
The safety and tolerability of a single oral dose of a fixed and free combination aliskiren/valsartan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416468
- Sponsor's protocol ID
- CSPV100A2101
- Status last verified
- Jun 2007
- First submitted
- 27 Dec 2006
- Last updated
- 22 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00416468
- Acronym / sponsor ID
- CSPV100A2101
- Conditions
- Healthy
- Keywords
- Aliskiren , Valsartan, bioavailability, hypertension, Healthy male and female subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- First posted
- 28 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aliskiren | Drug | – |
| Valsartan | Drug | – |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2007.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis principal investigator
Investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aliskiren and Valsartan in people with Healthy, run by Novartis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2007.