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.

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.

Study Overview

• Status: Completed
• Conditions: Clinical Pharmacology
• Intervention / Treatment: Drug: Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Wuppertal, Nordrhein-Westfalen, Germany, 42096

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nifedipine + Candesartan cilexetil; Coadministration of single doses of nifedipine and candesartan tablets	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Outcome 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: 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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2010
• Primary Completion (ACTUAL): June 7, 2010
• Study Completion (ACTUAL): June 7, 2010

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (ACTUAL): May 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Tocolytic Agents; Nifedipine; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: 14026; 2010-018958-12 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No