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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02332044

Enrollment

Registered

2015-01-06

Start date

2014-04-30

Completion date

2015-01-31

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGErdos

capsule, 300mg

DRUGTalion

tablet, 10mg

DRUGErdos, Talion

capsule 300mg and tablet 10mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026