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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Erdosteine 300mg

Group Type EXPERIMENTAL

Erdos

Intervention Type DRUG

capsule, 300mg

Bepotastine besilate 10mg

Group Type EXPERIMENTAL

Talion

Intervention Type DRUG

tablet, 10mg

Erdosteine 300mg + Bepotastine besilate 10mg

Group Type EXPERIMENTAL

Erdos, Talion

Intervention Type DRUG

capsule 300mg and tablet 10mg

Interventions

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Erdos

capsule, 300mg

Intervention Type DRUG

Talion

tablet, 10mg

Intervention Type DRUG

Erdos, Talion

capsule 300mg and tablet 10mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes