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.

April 28, 2017 updated by: Bayer
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Wuppertal, Nordrhein-Westfalen, Germany, 42096

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers
  • Age 30-55 years
  • BMI 18.0-29.9 kg/m²
  • Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Nifedipine + Candesartan cilexetil
Coadministration of single doses of nifedipine and candesartan tablets
Drug: Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 weeks
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.
7 weeks
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)
Time Frame: 48 hours
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
48 hours
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)
Time Frame: 48 hours
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
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
48 hours
Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)
Time Frame: 48 hours
48 hours
Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))
Time Frame: 48 hours
48 hours
Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax)
Time Frame: 48 hours
48 hours
Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)
Time Frame: 48 hours
48 hours
Pharmacokinetic parameters: Mean residence time (MRT)
Time Frame: 48 hours
48 hours
Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f)
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14026
  • 2010-018958-12 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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