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

A Randomized, Open Label, Single-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between DW330SR and DW1030 in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DW330SR 45mg; Drug: DW1030 75mg

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center IRB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; only DW330SR 45mg	Drug: DW330SR 45mg
Experimental: B; only DW1030 75mg	Drug: DW1030 75mg
Experimental: C; DW330SR 45mg and DW1030 75mg	Drug: DW330SR 45mg; Drug: DW1030 75mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: February 23, 2014
• First Posted (Estimate): February 25, 2014

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: DW340-1001