check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

14026

ClinicalTrials.gov Identifier:

NCT03136666

EudraCT Number:

2010-018958-12

EU CT Number:

Not Available
Single dose escalation study to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipne GITS and candesartan tablets under fasting conditions in healthy male subjects in an open label, non-randomized, sequential design.

Trial purpose

The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.

Key Participants Requirements

Sex

Male

Age

30 - 55 Years
  • - Healthy male volunteers
    - Age 30-55 years
    - BMI 18.0-29.9 kg/m²
    - Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg

Trial summary

Enrollment Goal
12
Trial Dates
April 2010 - June 2010
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
Wuppertal, 42096, Germany

Primary Outcome

  • Overall summary of adverse events as a measure of safety and tolarability
    Overview of treatment emergent adverse events and drug related adverse events, including information on severity as well as premature termination of study participation due to adverse events.
    date_rangeTime Frame:
    7 weeks
  • Safety related laboratory findings
    Laboratory parameters were evaluated in terms of multiples of their upper limits of normal. Changes were considered relevant, if they were at least 1.5 times above the upper limit of normal.
    date_rangeTime Frame:
    7 weeks
  • Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D)
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC)
    date_rangeTime Frame:
    48 hours

Secondary Outcome

  • Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm)
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax)
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: Mean residence time (MRT)
    date_rangeTime Frame:
    48 hours
  • Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f)
    date_rangeTime Frame:
    48 hours

Trial design

Single dose escalation study to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipne GITS and candesartan tablets under fasting conditions in healthy male subjects in an open label, non-randomized, sequential design.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.