Clinical trial NCT03136666: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Pharmacology
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-05-02
Enrollment: 12
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Overall summary of adverse events as a measure of safety and tolarability
timeFrame: 7 weeks
measure: Safety related laboratory findings
timeFrame: 7 weeks
measure: Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)
timeFrame: 48 hours
measure: Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D)
timeFrame: 48 hours
measure: Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)
timeFrame: 48 hours
measure: Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC)
timeFrame: 48 hours
Secondary outcomes:
measure: Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm)
timeFrame: 48 hours
measure: Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)
timeFrame: 48 hours
measure: Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))
timeFrame: 48 hours
measure: Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax)
timeFrame: 48 hours
measure: Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)
timeFrame: 48 hours
measure: Pharmacokinetic parameters: Mean residence time (MRT)
timeFrame: 48 hours
measure: Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: