check_circleStudy Completed

Hypertension, Essential

Pivotal bioequivalence FDC nifedipine / candesartan vs. loose combination of single components, fed

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
49
Trial Dates
April 2011 - September 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bayer Pharma AGBerlin, 13353, Germany

Primary Outcome

  • Cmax
    Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
    date_rangeTime Frame:
    within 48 hours after each dosing
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    Safety Issue:
    No
  • AUC(0-tlast)
    Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan
    date_rangeTime Frame:
    within 48 hours after each dosing
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    Safety Issue:
    No

Secondary Outcome

  • AUC
    Area under the curve from time 0 to infinity after single dose for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each dosing
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    Safety Issue:
    No
  • Cmax,norm
    Dose normalized Cmax for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each dosing
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    Safety Issue:
    No
  • AUCnorm
    AUC normalized for dose and body weight for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each dosing
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-48)
    Area under the plasma concentration–time curve from time zero to 48h for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each dosing
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    Safety Issue:
    No
  • Tmax
    The time of the maximum concentration for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each dosing
    enhanced_encryption
    Safety Issue:
    No
  • t1/2
    Half-life for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each dosing
    enhanced_encryption
    Safety Issue:
    No
  • MRT
    The mean residence time for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each dosing
    enhanced_encryption
    Safety Issue:
    No
  • CL/F
    Oral plasma clearances for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each dosing
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 3-7 weeks per subject
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2