HealthyPhase 1NCT00905333
Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal
A Phase 1 study testing Candesartan (test), Felodipine (test) and Candesartan Cilexetil in people with Healthy, run by AstraZeneca at 2 sites in Brazil.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil® Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Candesartan (test), Felodipine (test) and Candesartan Cilexetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2008to Nov 2008
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)
Who cannot join
- Not healthy
- Chronic drug intake
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.
The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®
- Conditions
- Healthy
- Being tested
- Candesartan (test), Felodipine (test), Candesartan Cilexetil, Felodipine
- Keywords
- pharmacokinetics, candesartan, felodipine, test formulations, Atacand®, Splendil®, healthy volunteers, blood samples, after meal intake interaction, Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan (test)Drug
16 mg oral tablet, single dose
Felodipine (test)Drug
5 mg oral extended release tablet, single dose
Candesartan CilexetilDrug
Also called Atacand®
16 mg oral tablet, single dose
FelodipineDrug
Also called Splendil®
5 mg oral extended release tablet, single dose
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Other | 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan) Receives: Drug: Candesartan (test); Drug: Felodipine (test); Drug: Candesartan Cilexetil; Drug: Felodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.
Measured: 76 blood samples per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startOct 2008
- Primary completionNov 2008
- Study completionNov 2008
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scentryphar Clinical Research, Cori Analyticals, Hospital Sirio-Libanes, LabClin Laboratório Clínico, Laboratório de Patologia Clínica Dr. Franceschi Ltda., Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center
- Investigators
- Eduardo Abib Junior, MD, Principal investigator, Scentryphar Clinical ResearchMoises L. P Vanuncci, MD, Study chair, Scentryphar Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905333
- Sponsor's protocol ID
- D2452L00021
- Other IDs
- IMPACT 15381
- Status last verified
- Dec 2010
- First submitted
- 19 May 2009
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.
- ClinicalTrials.gov ID
- NCT00905333
- Acronym / sponsor ID
- D2452L00021
- Conditions
- Healthy
- Keywords
- pharmacokinetics, candesartan, felodipine, test formulations, Atacand®, Splendil®, healthy volunteers, blood samples
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Scentryphar Clinical Research, Cori Analyticals, Hospital Sirio-Libanes, LabClin Laboratório Clínico, Laboratório de Patologia Clínica Dr. Franceschi Ltda., Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 May 2009 (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.
The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®
Study design
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Other | Drug: Candesartan (test), Drug: Felodipine (test), Drug: Candesartan Cilexetil, Drug: Felodipine3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)
Key exclusion criteria (2 listed)
- Not healthy
- Chronic drug intake
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 |
|---|---|---|
| Candesartan (test)16 mg oral tablet, single dose | Drug | Single-arm |
| Felodipine (test)5 mg oral extended release tablet, single dose | Drug | Single-arm |
| Candesartan CilexetilAlso: Atacand®16 mg oral tablet, single dose | Drug | Single-arm |
| FelodipineAlso: Splendil®5 mg oral extended release tablet, single dose | Drug | Single-arm |
Primary outcome
Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.
Time frame: 76 blood samples per subject
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 7 Dec 2010.
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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.
Eduardo Abib Junior, MD principal investigator
Scentryphar Clinical Research
Moises L. P Vanuncci, MD study chair
Scentryphar Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Candesartan (test), Felodipine (test) and Candesartan Cilexetil in people with Healthy, run by AstraZeneca at 2 sites in Brazil.
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 2 inclusion and 2 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 7 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. (time frame: 76 blood samples per subject). 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 7 Dec 2010.