Clinical PharmacologyPhase 1NCT03136666
Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.
A Phase 1 study testing Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil in people with Clinical Pharmacology, run by Bayer at 1 site in Germany.
Trial summary
The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology
- What is being tested?
- Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 19 Apr 2010to 7 Jun 2010
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Age 30-55 years
- BMI 18.0-29.9 kg/m²
- Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.
Read the detailed description
- Treatment period 1: Single oral dose of 30 mg nifedipine GITS and 8 mg candesartan as loose combination (Treatment A)
- Treatment period 2: Single oral dose of 60 mg nifedipine GITS and 16 mg candesartan as loose combination (Treatment B)
- Treatment period 3: single oral dose of 60 mg nifedipine GITS and 32 mg candesartan as loose combination (Treatment C) Before any study drug administration in each treatment period, subjects were fasted from food for at least 10 hours. Subjects continued fasting until at least 4 hours after study drug administration. The wash-out phase between treatments was 5 days.
The blood collection period for pharmacokinetics after administration was 48 h. Afterwards, subjects were discharged from the ward. A safety follow-up visit was performed approximately 7 days after the last administration.
- Conditions
- Clinical Pharmacology
- Being tested
- Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetilDrug
Candesartan and nifedipine were administered together as loose combination with 240 mL non-sparkling water in the morning after a fasting period of at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine + Candesartan cilexetil | Experimental | Coadministration of single doses of nifedipine and candesartan tablets Receives: Drug: Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall summary of adverse events as a measure of safety and tolarability
Overview of treatment emergent adverse events and drug related adverse events, including information on severity as well as premature termination of study participation due to adverse events.
Measured: 7 weeks
Safety related laboratory findings
Laboratory parameters were evaluated in terms of multiples of their upper limits of normal. Changes were considered relevant, if they were at least 1.5 times above the upper limit of normal.
Measured: 7 weeks
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)
Measured: 48 hours
Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D)
Measured: 48 hours
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)
Measured: 48 hours
Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC)
Measured: 48 hours
Secondary outcomes (7)
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm)
Measured: 48 hours
Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)
Measured: 48 hours
Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))
Measured: 48 hours
Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax)
Measured: 48 hours
Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)
Measured: 48 hours
Pharmacokinetic parameters: Mean residence time (MRT)
Measured: 48 hours
Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start19 Apr 2010
- Primary completion7 Jun 2010
- Study completion7 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03136666
- Sponsor's protocol ID
- 14026
- Other IDs
- 2010-018958-12
- Status last verified
- Apr 2017
- First submitted
- 28 Apr 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.
- ClinicalTrials.gov ID
- NCT03136666
- Acronym / sponsor ID
- 14026
- Conditions
- Clinical Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2010 (actual)
- Primary completion
- 7 Jun 2010 (actual)
- Study completion
- 7 Jun 2010 (actual)
- First posted
- 2 May 2017 (actual)
- 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 objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.
Detailed description
- Treatment period 1: Single oral dose of 30 mg nifedipine GITS and 8 mg candesartan as loose combination (Treatment A)
- Treatment period 2: Single oral dose of 60 mg nifedipine GITS and 16 mg candesartan as loose combination (Treatment B)
- Treatment period 3: single oral dose of 60 mg nifedipine GITS and 32 mg candesartan as loose combination (Treatment C) Before any study drug administration in each treatment period, subjects were fasted from food for at least 10 hours. Subjects continued fasting until at least 4 hours after study drug administration. The wash-out phase between treatments was 5 days.
The blood collection period for pharmacokinetics after administration was 48 h. Afterwards, subjects were discharged from the ward. A safety follow-up visit was performed approximately 7 days after the last administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nifedipine + Candesartan cilexetil | Experimental | Drug: Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetilCoadministration of single doses of nifedipine and candesartan tablets |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers
- Age 30-55 years
- BMI 18.0-29.9 kg/m²
- Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
Key exclusion criteria (0 listed)
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 gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetilCandesartan and nifedipine were administered together as loose combination with 240 mL non-sparkling water in the morning after a fasting period of at least 10 hours. | Drug | Nifedipine + Candesartan cilexetil |
Primary outcome
Overall summary of adverse events as a measure of safety and tolarability
Time frame: 7 weeks
Overview of treatment emergent adverse events and drug related adverse events, including information on severity as well as premature termination of study participation due to adverse events.
Safety related laboratory findings
Time frame: 7 weeks
Laboratory parameters were evaluated in terms of multiples of their upper limits of normal. Changes were considered relevant, if they were at least 1.5 times above the upper limit of normal.
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)
Time frame: 48 hours
Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D)
Time frame: 48 hours
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)
Time frame: 48 hours
Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC)
Time frame: 48 hours
7 secondary outcomes
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm)
Time frame: 48 hours
Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)
Time frame: 48 hours
Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))
Time frame: 48 hours
Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax)
Time frame: 48 hours
Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)
Time frame: 48 hours
Pharmacokinetic parameters: Mean residence time (MRT)
Time frame: 48 hours
Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f)
Time frame: 48 hours
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 2 May 2017.
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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 gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil in people with Clinical Pharmacology, 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 4 inclusion and 0 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 2 May 2017. 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?
Overall summary of adverse events as a measure of safety and tolarability (time frame: 7 weeks). The study lists 6 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 2 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.