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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01227603
First received: October 22, 2010
Last updated: December 8, 2015
Last verified: December 2015

October 22, 2010
December 8, 2015
November 2010
March 2011   (final data collection date for primary outcome measure)
  • Cmax [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
  • AUC(0-tn) [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    AUC from time 0 to the last data point for nifedipine and candesartan
  • C(max) and AUC(0-tn) for nifedipine [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
  • C(max) and AUC(0-tn) for candesartan [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01227603 on ClinicalTrials.gov Archive Site
  • AUC [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan
  • Cmax,norm [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan
  • AUCnorm [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    Area under the curve divided by dose per kg body weight for nifedipine and candesartan
  • AUC(0-48) [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    AUC from time 0 to time 48 h for nifedipine and candesartan
  • tmax [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan
  • t½ [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    Half-life associated with the terminal slope for nifedipine and candesartan
  • MRT [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    Mean residence time for nifedipine and candesartan
  • CL/f [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan
  • Number of participants with adverse events [ Time Frame: Approximately 3.5 months ] [ Designated as safety issue: Yes ]
Further pharmakokinetic parameters (AUC, C(max,norm), AUCnorm, AUC(0-48), tmax and t1/2) for nifedipine and candesartan [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension, Essential
  • Drug: Nifedipine-candesartan FDC (BAY 98-7106)
    Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
  • 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
  • Experimental: Nifedipine-candesartan FDC
    Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.
    Intervention: Drug: Nifedipine-candesartan FDC (BAY 98-7106)
  • 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.
    Interventions:
    • Drug: Nifedipine GITS (Adalat LA, BAYA1040)
    • Drug: Candesartan (Atacand)
  • Active Comparator: Nifedipine
    Each subject received one dose of nifedipine GITS 60 mg orally.
    Intervention: Drug: Nifedipine GITS (Adalat LA, BAYA1040)
  • Active Comparator: Candesartan
    Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.
    Intervention: Drug: Candesartan (Atacand)
Brendel E, Weimann B, Dietrich H, Froede C, Thomas D. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions. Int J Clin Pharmacol Ther. 2013 Sep;51(9):753-62. doi: 10.5414/CP201879.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
July 2011
March 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01227603
14027, 2010-021966-31
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP