NCT03136666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2010

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

April 28, 2017

Last Update Submit

April 28, 2017

Conditions

Clinical Pharmacology

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Nifedipine + Candesartan cilexetil

EXPERIMENTAL

Coadministration of single doses of nifedipine and candesartan tablets

Drug: Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil

Interventions

Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetilDRUG

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.

Nifedipine + Candesartan cilexetil

Eligibility Criteria

Age30 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Wuppertal, North Rhine-Westphalia, 42096, Germany

Location

MeSH Terms

Interventions

Nifedipinecandesartan cilexetil

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 2, 2017

Study Start

April 19, 2010

Primary Completion

June 7, 2010

Study Completion

June 7, 2010

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

DE(1)