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A Multiple Dose Study of DWP05195 in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01094834
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : February 9, 2011
Information provided by:
Daewoong Pharmaceutical Co. LTD.

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

Condition or disease Intervention/treatment Phase
Healthy Adult Volunteers Drug: DWP05195 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: A Multiple Dose Study To Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP05195 in Healthy Adult Subjects
Study Start Date : April 2010
Actual Primary Completion Date : October 2010

Arm Intervention/treatment
Experimental: DWP05195 Drug: DWP05195
tablets, oral administration, multiple administration

Primary Outcome Measures :
  1. Assessment of safety & tolerability: adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination [ Time Frame: 17 days after drug administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy adult male subjects aged 20 to 45 years
  2. 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.
  3. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
  4. 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:

1. 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
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Responsible Party: Daewoong Pharmaceutical Co.LTD. Identifier: NCT01094834    
Other Study ID Numbers: DWP05195-P002
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: February 9, 2011
Last Verified: February 2011