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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02332044
• Collaborator: (none)
• Enrollment: 36
• Arms: 3
• Duration (Months): 9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Erdos; Drug: Talion; Drug: Erdos, Talion	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official 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
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erdosteine 300mg	Drug: Erdos; capsule, 300mg
Experimental: Bepotastine besilate 10mg	Drug: Talion; tablet, 10mg
Experimental: Erdosteine 300mg + Bepotastine besilate 10mg	Drug: Erdos, Talion; capsule 300mg and tablet 10mg

Outcome Measures

Primary Outcome Measures

1. Cmax [Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment]

2. AUClast [Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT02332044
• Other Study ID Numbers: DW_DWJ1340001
• First Posted: Jan 6, 2015
• Last Update Posted: Jan 6, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Bepotastine besilate

Study Results

No Results Posted as of Jan 6, 2015