DWP05195 in Healthy Adult Male Volunteers

NCT ID: NCT00969787

Last Updated: 2010-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30

Brief Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: DOUBLE

Study Groups

DWP05195

Group Type: EXPERIMENTAL

DWP05195

Intervention Type: DRUG

tablets, oral administration, single and multiple administrations

Interventions

DWP05195

tablets, oral administration, single and multiple administrations

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adult male subjects aged 20 to 45 years
• The subject has a Body weight ≥ 50 kg and < 90 kg and Body Mass Index (BMI) ≥ 19.0 kg/m2 and < 27.0 kg/m2
• A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
• 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)

Exclusion Criteria

• A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
• A subject who had any allergic history to any drug (prescription drug or OTC medication etc.)
• A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication

• Within last 1 month: drug or food known CYP1A2 inducer or inhibitor
• Within 2 weeks: Prescribed or herbal or Non-prescribed medicine
• Within 3 days: Consumption of grapefruit juice/grapefruit containing products or orange juice/orange containing products, garlic extracted functional foods
• Within 3 days: Consumption of alcohol or caffeine
• A subject who had participated in any other clinical study within the last 12 weeks
• A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks
• A Subject with the known evidence of the following infections or drug abuse
• HIV, HBs, HCV
• cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine
• Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test
• AST or ALT greater than 1.5 times the upper limit of reference range or QTc > 430 msec base on screening results
• Blood pressure: SBP ≥ 140 mmHg, DBP ≤ 85 mmHg
• A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Daewoong Pharmaceutical Co. LTD

Principal Investigators

Kyung-Sang Yu

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DWP05195-P001

Identifier Type: -

Identifier Source: org_study_id