Hypertension, EssentialPhase 1NCT01350609
Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed
A Phase 1 study testing Nifedipine/Candesartan (BAY 98-7106) and Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333) in people with Hypertension, Essential, run by Bayer at 1 site in Germany.
Trial summary
Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Essential
- What is being tested?
- Nifedipine/Candesartan (BAY 98-7106) and Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Sep 2011
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The informed consent form must be signed before any study specific tests or procedures are done
- Confirmation of the subject's health insurance coverage prior to the first screening visit
- Healthy male subject
- Ethnicity: Caucasian
- Age: 18 to 45 years (inclusive) at the first screening visit
- Body mass index (BMI) above or equal 18, and below or equal 29.9 kg / m²
- Ability to understand and follow study-related instructions
Who cannot join
- Suspicion of drug or alcohol abuse
- Regular daily consumption of more than 1 L of xanthin-containing beverages
- Intake of foods or beverages containing grapefruit within 2 weeks prior to the first study drug administration (the same applies to pomelos and St. John's Wort)
- Use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. CYP3A inhibitors or CYP3A inducers)
- examples for CYP3A inhibitors: erythromycin, inhibitors of human HIV protease (e.g. ritonavir, saquinavir), amiodarone, diltiazem, verapamil, fluconazole, itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodon, cimetidine;
- examples for CYP3A inducers: rifampicin, carbamazepin, phenytoin, phenobarbital, or products containing St. John's Wort;
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- Systolic blood pressure below 116 or above 145 mmHg (after at least 15 min supine)
- At the first screening visit
- Diastolic blood pressure above 95 mmHg (after at least 15 min supine)
- Heart rate below 45 or above 95 beats / min (after at least 15 min supine) at the first screening visit
- Clinically relevant findings in the physical examination
- Positive urine drug screening or alcohol breath test
- Exclusion periods from other studies or simultaneous participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan and the Loose Combination of Both Components and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Subjects Under Fed Conditions in an Open Label, Randomized, 2-way-crossover Design
Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.
Read the detailed description
Clinical pharmacology
- Conditions
- Hypertension, Essential
- Being tested
- Nifedipine/Candesartan (BAY 98-7106), Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
- Keywords
- essential hypertension, blood pressure, nifedipine, candesartan, FDC
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine/Candesartan (BAY 98-7106)Drug
Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)Drug
Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine/Candesartan (fixed dose) | Experimental | Not described Receives: Drug: Nifedipine/Candesartan (BAY 98-7106) |
| Nifedipine/Candesartan (loose) | Active comparator | Not described Receives: Drug: Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
Measured: within 48 hours after each dosing
AUC(0-tlast)
Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan
Measured: within 48 hours after each dosing
Secondary outcomes (9)
AUC
Area under the curve from time 0 to infinity after single dose for nifedipine and candesartan
Measured: Within 48 hours after each dosing
Cmax,norm
Dose normalized Cmax for nifedipine and candesartan
Measured: Within 48 hours after each dosing
AUCnorm
AUC normalized for dose and body weight for nifedipine and candesartan
Measured: Within 48 hours after each dosing
AUC(0-48)
Area under the plasma concentration-time curve from time zero to 48h for nifedipine and candesartan
Measured: Within 48 hours after each dosing
Tmax
The time of the maximum concentration for nifedipine and candesartan
Measured: Within 48 hours after each dosing
t1/2
Half-life for nifedipine and candesartan
Measured: Within 48 hours after each dosing
MRT
The mean residence time for nifedipine and candesartan
Measured: Within 48 hours after each dosing
CL/F
Oral plasma clearances for nifedipine and candesartan
Measured: Within 48 hours after each dosing
Number of participants with adverse events
Measured: Approximately 3-7 weeks per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, EssentialStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350609
- Sponsor's protocol ID
- 14028
- Other IDs
- 2011-000322-29
- Status last verified
- Dec 2015
- First submitted
- 18 Apr 2011
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan and the Loose Combination of Both Components and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Subjects Under Fed Conditions in an Open Label, Randomized, 2-way-crossover Design
- ClinicalTrials.gov ID
- NCT01350609
- Acronym / sponsor ID
- 14028
- Conditions
- Hypertension, Essential
- Keywords
- essential hypertension, blood pressure, nifedipine, candesartan, FDC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 May 2011 (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.
Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.
Detailed description
Clinical pharmacology
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine/Candesartan (fixed dose) | Experimental | Drug: Nifedipine/Candesartan (BAY 98-7106) |
| Nifedipine/Candesartan (loose) | Active comparator | Drug: Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The informed consent form must be signed before any study specific tests or procedures are done
- Confirmation of the subject's health insurance coverage prior to the first screening visit
- Healthy male subject
- Ethnicity: Caucasian
- Age: 18 to 45 years (inclusive) at the first screening visit
Key exclusion criteria (13 listed)
- Suspicion of drug or alcohol abuse
- Regular daily consumption of more than 1 L of xanthin-containing beverages
- Intake of foods or beverages containing grapefruit within 2 weeks prior to the first study drug administration (the same applies to pomelos and St. John's Wort)
- Use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. CYP3A inhibitors or CYP3A inducers)
- Systolic blood pressure below 116 or above 145 mmHg (after at least 15 min supine)
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 |
|---|---|---|
| Nifedipine/Candesartan (BAY 98-7106)Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period) | Drug | Nifedipine/Candesartan (fixed dose) |
| Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) . | Drug | Nifedipine/Candesartan (loose) |
Primary outcome
Cmax
Time frame: within 48 hours after each dosing
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
AUC(0-tlast)
Time frame: within 48 hours after each dosing
Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan
9 secondary outcomes
AUC
Time frame: Within 48 hours after each dosing
Cmax,norm
Time frame: Within 48 hours after each dosing
AUCnorm
Time frame: Within 48 hours after each dosing
AUC(0-48)
Time frame: Within 48 hours after each dosing
Tmax
Time frame: Within 48 hours after each dosing
t1/2
Time frame: Within 48 hours after each dosing
MRT
Time frame: Within 48 hours after each dosing
CL/F
Time frame: Within 48 hours after each dosing
Number of participants with adverse events
Time frame: Approximately 3-7 weeks 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 10 Dec 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
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 Nifedipine/Candesartan (BAY 98-7106) and Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333) in people with Hypertension, Essential, run by Bayer at 1 site in Germany.
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 7 inclusion and 13 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 10 Dec 2015. 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 Germany. 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?
Cmax (time frame: within 48 hours after each dosing). The study lists 2 primary outcomes in all. 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 10 Dec 2015.