A Multiple Dose Study of DWP05195 in Healthy Adult Subjects

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple administered DWP05195 in healthy volunteers

Completed

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Key information

Conditions

Healthy Adult Volunteers

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 2. A subject who had any allergic history to any drug (prescription drug or OTC medication etc.) 3. 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 4. A subject who had participated in any other clinical study within the last 12 weeks 5. A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks 6. A Subject with the known evidence of the following infections or drug abuse
HIV, HBs, HCV
cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine 7. Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test 8. AST or ALT greater than 1.5 times the upper limit of reference range or QTc > 430 msec base on screening results 9. Blood pressure : SBP≥140mmHg, DBP≤85mmHg 10. A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests

Treatment and study plan

DWP05195

Drug

tablets, oral administration, multiple administration

Primary outcomes

Assessment of safety & tolerability: adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination

Time frame: 17 days after drug administration

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Multiple Dose Study To Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP05195 in Healthy Adult Subjects

Important dates

Study start: 2010
Primary completion: 2010
First posted: Mar 29, 2010
Registry last updated: Feb 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed