Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers

October 11, 2016 updated by: Daewon Pharmaceutical Co., Ltd.
A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age at screening visit only 20 healthy men over the age of 40 years or less
  • Screening visit, BMI measurement is more than 19 kg/m2 who are below 27 kg/m2
  • Screening vist, 90 mmHg ≤ SBP ≤ 140 mmHg, 50 mmHg ≤ DBP ≤ 90 mmHg
  • Fully understand the purpose of trial, test drug and follow the instructions of the trial, Those who voluntarily written consent that ability and decision to participate during the entire period of the test

Exclusion Criteria:

  • Those with a clinically significant history or character; Liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood • tumor type, cardiovascular disease
  • Those with Gastrointestinal diseases that may affect the absorption of the IND or history of surgery
  • Those who have a clinically significant history of hypersensitivity to drug and food
  • Those with genetic problems, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption
  • Within 60 days those taking the other clinical trial drug
  • Within 30 days those who take the drug metabolizing enzyme induction and inhibition drugs or prescription drugs
  • Within 30 days those who take food abnormally, that may affect ADME of drug
  • Within 60 days those who donate whole blood, within 30 days those who donate blood partially, receive transfusion
  • Within 14 days those who take OTC drug
  • Those who showing positive for drug abuse concerns in urine drug testing
  • Those who drink excessive alcohol or have history of alcoholism
  • Heavy smoker
  • and so on

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test 1
First phase: DW330SR+DW1030 7 days after Second phase: DW340
Drug: combination drug: DW330SR, DW1030
Drug: DW340
Experimental: Test 2
First phase: DW340 7 days after Second phase: DW330SR+DW1030
Drug: combination drug: DW330SR, DW1030
Drug: DW340

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of DW330SR
Time Frame: 9 days
9 days
Cmax of DW340
Time Frame: 9 days
9 days
Cmax of DW1030
Time Frame: 9 days
9 days
AUClast of DW330SR
Time Frame: 9 days
9 days
AUClast of DW340
Time Frame: 9 days
9 days
AUClast of DW1030
Time Frame: 9 days
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 1, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DW340-1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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