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NCT Number: NCT02286934

Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

About this study

This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Subjects aged 20 - 45 years
  • A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).
  • Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion criteria

  • Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
  • Subject judged not eligible for study participation by investigator.

Treatment and study plan

Carvedilol

Drug
  • Day 1 to 3 : Carvedilol 12.5 mg qd
  • Day 4 to 8 : Carvedilol 25 mg qd
  • Day 9 to 11 : Carvedilol 12.5 mg qd

Isoproterenol Sensitivity Test

Other

Day 0, 1, 8 : Isoproterenol Sensitivity Test

Primary outcomes

  1. AUC (area under the plasma concentration-time curve) of carvedilol

    Time frame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose

  2. Cmax (Maximum plasma concentration) of carvedilol

    Time frame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Institute of Food and Drug Safety Evaluation, Korea

Registry information

Official study title

A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 10, 2014
Registry last updated
Jun 4, 2015

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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