Trial Condition(s):
Clinical Pharmacology
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.
Bayer Identifier:
14026
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
: - Healthy male volunteers - Age 30-55 years - BMI 18.0-29.9 kg/m² - Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Wuppertal, Germany, 42096 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Overall summary of adverse events as a measure of safety and tolarabilityOverview 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.Timeframe: 7 weeks
- Safety related laboratory findingsLaboratory 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.Timeframe: 7 weeks
- Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)Timeframe: 48 hours
- Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D)Timeframe: 48 hours
- Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)Timeframe: 48 hours
- Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC)Timeframe: 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)Timeframe: 48 hours
- Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)Timeframe: 48 hours
- Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))Timeframe: 48 hours
- Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax)Timeframe: 48 hours
- Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)Timeframe: 48 hours
- Pharmacokinetic parameters: Mean residence time (MRT)Timeframe: 48 hours
- Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f)Timeframe: 48 hours
Additional Information
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