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Trial record 1 of 1 for:    NCT03136666
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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.

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ClinicalTrials.gov Identifier: NCT03136666
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Clinical Pharmacology Drug: Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 19, 2010
Actual Primary Completion Date : June 7, 2010
Actual Study Completion Date : June 7, 2010

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers
  • Age 30-55 years
  • BMI 18.0-29.9 kg/m²
  • Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136666


Locations
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Germany
Wuppertal, Nordrhein-Westfalen, Germany, 42096
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03136666    
Other Study ID Numbers: 14026
2010-018958-12 ( EudraCT Number )
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candesartan
Candesartan cilexetil
Nifedipine
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
 Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents