NCT02332044

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2014

Typical duration for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

January 4, 2015

Last Update Submit

January 4, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Erdosteine 300mg

EXPERIMENTAL
Drug: Erdos

Bepotastine besilate 10mg

EXPERIMENTAL
Drug: Talion

Erdosteine 300mg + Bepotastine besilate 10mg

EXPERIMENTAL
Drug: Erdos, Talion

Interventions

ErdosDRUG

capsule, 300mg

Erdosteine 300mg
TalionDRUG

tablet, 10mg

Bepotastine besilate 10mg
Erdos, TalionDRUG

capsule 300mg and tablet 10mg

Erdosteine 300mg + Bepotastine besilate 10mg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 6, 2015

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

January 1, 2015

Last Updated

January 6, 2015

Record last verified: 2015-01