Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions

December 8, 2015 updated by: Bayer

Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-way-crossover Design

Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • 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
      • Köln, Nordrhein-Westfalen, Germany, 51063

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

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subject
  • Age: 18 to 45 years (inclusive) at the first screening / examination visit
  • Ethnicity: Caucasian
  • Body mass index (BMI): >/=18 and </=29,9 kg/m²

Exclusion Criteria:

  • Systolic blood pressure below 120 or above 145 mmHg
  • Diastolic blood pressure above 95 mmHg
  • Heart rate below 45 or above 95 beats / min
  • Clinically relevant findings in the physical examination
  • 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 4 weeks before the pre-study examination

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nifedipine-candesartan FDC
Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.
Drug: Nifedipine-candesartan FDC (BAY 98-7106)
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
Active Comparator: Nifedipine and candesartan
Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.
Drug: Nifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Drug: Candesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
Active Comparator: Nifedipine
Each subject received one dose of nifedipine GITS 60 mg orally.
Drug: Nifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Active Comparator: Candesartan
Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.
Drug: Candesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Within 48 hours after each treatment
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
Within 48 hours after each treatment
AUC(0-tn)
Time Frame: Within 48 hours after each treatment
AUC from time 0 to the last data point for nifedipine and candesartan
Within 48 hours after each treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: Within 48 hours after each treatment
Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan
Within 48 hours after each treatment
Cmax,norm
Time Frame: Within 48 hours after each treatment
Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan
Within 48 hours after each treatment
AUCnorm
Time Frame: Within 48 hours after each treatment
Area under the curve divided by dose per kg body weight for nifedipine and candesartan
Within 48 hours after each treatment
AUC(0-48)
Time Frame: Within 48 hours after each treatment
AUC from time 0 to time 48 h for nifedipine and candesartan
Within 48 hours after each treatment
tmax
Time Frame: Within 48 hours after each treatment
Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan
Within 48 hours after each treatment
t½
Time Frame: Within 48 hours after each treatment
Half-life associated with the terminal slope for nifedipine and candesartan
Within 48 hours after each treatment
MRT
Time Frame: Within 48 hours after each treatment
Mean residence time for nifedipine and candesartan
Within 48 hours after each treatment
CL/f
Time Frame: Within 48 hours after each treatment
Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan
Within 48 hours after each treatment
Number of participants with adverse events
Time Frame: Approximately 3.5 months
Approximately 3.5 months

Collaborators and Investigators

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

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

November 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14027
  • 2010-021966-31 (EudraCT Number)

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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