Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients

A Phase I, Randomized, Open, Multi-center, Cross Over Study to Evaluate the Therapeutic Equivalence of Repeated Dose of HCP0910 250/50 μg to SeretideTM 250 DiskusTM in Asthmatic Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01521455

Enrollment

Registered

2012-01-30

Start date

2012-02-29

Completion date

2013-07-31

Last updated

2013-08-23

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

Conditions

Asthma

Brief summary

The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.

Interventions

DRUGHCP0910

250/50, BID for 2 weeks

DRUGSeretide Diskus

250/50, BID for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* age 20 \ 75 inclusive * Asthmatic diagnosis in more than 12 weeks from screening day * Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2

Exclusion criteria

* Maintain controlled asthma for more than 4 weeks before screening * Diagnosed as a severe asthmatic patients

Design outcomes

Primary

Measure	Time frame
mean change of morning predose FEV1 from baseline	day 14

Countries

South Korea

Outcome results

None listed

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