NCT02071381

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

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 30, 2015

Status Verified

January 1, 2014

Enrollment Period

2 months

First QC Date

February 21, 2014

Last Update Submit

March 26, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Trans-OH as Main Metabolites of DW330SR, DW330SR, Cmax, AUClast of DW1030

    -28 ~ -2day(screening), -1day, 1day, 2day

Study Arms (3)

A

EXPERIMENTAL

only DW330SR 45mg

Drug: DW330SR 45mg

B

EXPERIMENTAL

only DW1030 75mg

Drug: DW1030 75mg

C

EXPERIMENTAL

DW330SR 45mg and DW1030 75mg

Drug: DW330SR 45mgDrug: DW1030 75mg

Interventions

DW330SR 45mgDRUG
AC
DW1030 75mgDRUG
BC

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center IRB

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2014

First Posted

February 25, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 30, 2015

Record last verified: 2014-01

Locations

KR(1)