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Completed

NCT Number: NCT02332044

Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers

The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and Bepotastine besilate in healthy adult volunteers.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects aged 20 - 45 years
  • A body mass index in the range 18.5 - 25 kg/m2
  • Willingness to participate during the entire study period
  • Written informed consent after being fully informed about the study procedures

Exclusion criteria

  • Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
  • History of clinically significant drug hypersensitivity
  • Use of medication within 7 days before the first dose
  • Heavy drinker/smoker
  • Whole blood donation during 60 days before the study
  • Judged not eligible for study participation by investigator

Treatment and study plan

Erdos

Drug

capsule, 300mg

Talion

Drug

tablet, 10mg

Erdos, Talion

Drug

capsule 300mg and tablet 10mg

Primary outcomes

  1. Cmax

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

  2. AUClast

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, Three-treatment, Three-period, Six-sequence Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Erdosteine and Bepotastine Besilate After Oral Administration in Healthy Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 6, 2015
Registry last updated
Jan 6, 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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