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.
- Conditions
- Clinical Pharmacology
- Interventions
- Registration Number
- NCT03136666
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
- Healthy male volunteers
- Age 30-55 years
- BMI 18.0-29.9 kg/m²
- Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nifedipine + Candesartan cilexetil Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil Coadministration of single doses of nifedipine and candesartan tablets
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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: 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 Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f) 48 hours