Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DWP09031

DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Group Type EXPERIMENTAL

DWP09031

Intervention Type DRUG

DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Placebo

placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Interventions

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DWP09031

DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Intervention Type DRUG

Placebo

placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy adult male subjects aged 20 to 45 years
2. The subject has Broca's index ≤ 20%
3. A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
4. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria

1. A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
2. A subject who shows vital signs with the number of systolic blood pressure of ≥141 mmHg or ≤89 mmHg, and the number of diastolic blood pressure of ≥91mmHg
3. A subject who shows the following result in clinical laboratory test:

AST,ALT\>1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec creatinine clearance ≤ 80mL/min
4. Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes