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NCT03136666 Clinical Trial

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.

Clinical Pharmacology Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03136666
Other study ID # 14026
Secondary ID 2010-018958-12
Status Completed
Phase Phase 1
First received April 28, 2017
Last updated April 28, 2017
Start date April 19, 2010
Est. completion date June 7, 2010

Study information
Verified date April 2017
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 12
Est. completion date June 7, 2010
Est. primary completion date June 7, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male volunteers

- Age 30-55 years

- BMI 18.0-29.9 kg/m²

- Systolic blood pressure (SBP) = 120 and = 145 mmHg

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nifedipine 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 7 weeks
Primary 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. 7 weeks
Primary Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D) 48 hours
Primary Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D) 48 hours
Primary Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax) 48 hours
Primary Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC) 48 hours
Secondary Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm) 48 hours
Secondary Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm) 48 hours
Secondary Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn)) 48 hours
Secondary Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax) 48 hours
Secondary Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2) 48 hours
Secondary Pharmacokinetic parameters: Mean residence time (MRT) 48 hours
Secondary Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f) 48 hours
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