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Completed

NCT Number: 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.

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.

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Key information

Conditions

Clinical Pharmacology

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Wuppertal, North Rhine-Westphalia, 42096, Germany

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Drug

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.

Primary outcomes

  1. Overall summary of adverse events as a measure of safety and tolarability

    Time frame: 7 weeks

    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.

  2. Safety related laboratory findings

    Time frame: 7 weeks

    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.

  3. Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)

    Time frame: 48 hours

  4. Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D)

    Time frame: 48 hours

  5. Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)

    Time frame: 48 hours

  6. Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC)

    Time frame: 48 hours

Secondary outcomes

  1. Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm)

    Time frame: 48 hours

  2. Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)

    Time frame: 48 hours

  3. Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))

    Time frame: 48 hours

  4. Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax)

    Time frame: 48 hours

  5. Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)

    Time frame: 48 hours

  6. Pharmacokinetic parameters: Mean residence time (MRT)

    Time frame: 48 hours

  7. Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f)

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 2, 2017
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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