check_circleStudy Completed

Hypertension, Essential

Bayer Identifier:

14027

ClinicalTrials.gov Identifier:

NCT01227603

EudraCT Number:

2010-021966-31

EU CT Number:

Not Available
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

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male subject
    - Age: 18 to 45 years (inclusive) at the first screening / examination visit
    - Ethnicity: Caucasian
    - Body mass index (BMI): >/=18 and
  • - 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

Trial summary

Enrollment Goal
49
Trial Dates
November 2010 - July 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
MEDA Manufacturing GmbH, ClinPharmCologneKöln, 51063, Germany

Primary Outcome

  • Cmax
    Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tn)
    AUC from time 0 to the last data point for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • AUC
    Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,norm
    Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • AUCnorm
    Area under the curve divided by dose per kg body weight for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-48)
    AUC from time 0 to time 48 h for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • tmax
    Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • t½
    Half-life associated with the terminal slope for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • MRT
    Mean residence time for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • CL/f
    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan
    date_rangeTime Frame:
    Within 48 hours after each treatment
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 3.5 months
    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, 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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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