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Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350609
First Posted: May 10, 2011
Last Update Posted: December 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
April 18, 2011
May 10, 2011
December 10, 2015
April 2011
August 2011   (Final data collection date for primary outcome measure)
  • 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
  • Maximum drug concentration in plasma (Cmax) of nifedipine and candesartan [ Time Frame: within 48 hours after each dosing ]
  • Area under the drug-concentration vs. time curve from time 0 to the last data point (AUC(0 tn)) of nifedipine and candesartan [ Time Frame: within 48 hours after each dosing ]
Complete list of historical versions of study NCT01350609 on ClinicalTrials.gov Archive Site
  • AUC [ Time Frame: Within 48 hours after each dosing ]
    Area under the curve from time 0 to infinity after single dose for nifedipine and candesartan
  • Cmax,norm [ Time Frame: Within 48 hours after each dosing ]
    Dose normalized Cmax for nifedipine and candesartan
  • AUCnorm [ Time Frame: Within 48 hours after each dosing ]
    AUC normalized for dose and body weight for nifedipine and candesartan
  • AUC(0-48) [ Time Frame: Within 48 hours after each dosing ]
    Area under the plasma concentration-time curve from time zero to 48h for nifedipine and candesartan
  • Tmax [ Time Frame: Within 48 hours after each dosing ]
    The time of the maximum concentration for nifedipine and candesartan
  • t1/2 [ Time Frame: Within 48 hours after each dosing ]
    Half-life for nifedipine and candesartan
  • MRT [ Time Frame: Within 48 hours after each dosing ]
    The mean residence time for nifedipine and candesartan
  • CL/F [ Time Frame: Within 48 hours after each dosing ]
    Oral plasma clearances for nifedipine and candesartan
  • Number of participants with adverse events [ Time Frame: Approximately 3-7 weeks per subject ]
  • Area under the curve (AUC) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ]
  • Dose normalized Cmax (Cmax,norm) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ]
  • AUC normalized for dose and body weight (AUCnorm) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ]
  • Area under the plasma concentration-time curve from time zero to 48h (AUC(0-48))of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ]
  • The time of the maximum concentration (Tmax) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ]
  • Half life (t1/2) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ]
  • The mean residence time (MRT) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ]
  • Oral plasma clearances (CL/F) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ]
Not Provided
Not Provided
 
Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed
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.
Clinical pharmacology
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Hypertension, Essential
  • Drug: Nifedipine/Candesartan (BAY 98-7106)
    Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
  • Drug: 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) .
  • Experimental: Nifedipine/Candesartan (fixed dose)
    Intervention: Drug: Nifedipine/Candesartan (BAY 98-7106)
  • Active Comparator: Nifedipine/Candesartan (loose)
    Intervention: Drug: Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
Not Provided

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01350609
14028
2011-000322-29 ( EudraCT Number )
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