Phase 1 Study of DDI Between DW330SR and DW1030 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DW330SR 45mg; Drug: DW1030 75mg

• Registration Number: NCT02071381
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-23
• Study First Posted: 2014-02-25
• Study Start: 2014-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy Adult males aged 20~40 years at screening visit

• Subjects with range of 19 kg/m2 ~ 27 kg/m2 as BMI measurements at screening visit

• Subjects with BP range of below:

  90 mmHg ≤ Systolic BP ≤ 140 mmHg 50 mmHg ≤ Diastolic BP ≤ 90mmHg

• Subjects who voluntarily agreed with written consent that be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the reguirement of the study

Exclusion Criteria

• Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)
• Subjects with history of gastrointestinal disease (ex, Chrones dz, peptic ulcer, etc) affect the absorption of Investigational drugs or history of surgery (except for a simple appendectomy or hernia surgery)
• Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID and antibiotics) including ingredient of DW330SR and DW1030 and Food

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C	DW330SR 45mg	DW330SR 45mg and DW1030 75mg
B	DW1030 75mg	only DW1030 75mg
C	DW1030 75mg	DW330SR 45mg and DW1030 75mg
A	DW330SR 45mg	only DW330SR 45mg

Primary Outcome Measures

Name	Time	Method
Trans-OH as Main Metabolites of DW330SR, DW330SR, Cmax, AUClast of DW1030	-28 ~ -2day(screening), -1day, 1day, 2day

Trial Locations

Locations (1)

Asan Medical Center IRB; 🇰🇷 Seoul, Korea, Republic of