Clinical Pharmacology
Conditions
Brief summary
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.
Detailed description
* Treatment period 1: Single oral dose of 30 mg nifedipine GITS and 8 mg candesartan as loose combination (Treatment A) * Treatment period 2: Single oral dose of 60 mg nifedipine GITS and 16 mg candesartan as loose combination (Treatment B) * Treatment period 3: single oral dose of 60 mg nifedipine GITS and 32 mg candesartan as loose combination (Treatment C) Before any study drug administration in each treatment period, subjects were fasted from food for at least 10 hours. Subjects continued fasting until at least 4 hours after study drug administration. The wash-out phase between treatments was 5 days. The blood collection period for pharmacokinetics after administration was 48 h. Afterwards, subjects were discharged from the ward. A safety follow-up visit was performed approximately 7 days after the last administration.
Interventions
DRUGNifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil
Candesartan and nifedipine were administered together as loose combination with 240 mL non-sparkling water in the morning after a fasting period of at least 10 hours.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers * Age 30-55 years * BMI 18.0-29.9 kg/m² * Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall summary of adverse events as a measure of safety and tolarability | 7 weeks | 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. |
| Safety related laboratory findings | 7 weeks | 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. |
| Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D) | 48 hours | — |
| Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D) | 48 hours | — |
| Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax) | 48 hours | — |
| Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC) | 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm) | 48 hours |
| Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f) | 48 hours |
| Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm) | 48 hours |
| Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn)) | 48 hours |
| Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax) | 48 hours |
| Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2) | 48 hours |
| Pharmacokinetic parameters: Mean residence time (MRT) | 48 hours |
Countries
Germany
Outcome results
None listed