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A Multiple Dose Study of DWP05195 in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01094834
First received: March 26, 2010
Last updated: February 8, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Adult Volunteers
 Drug: DWP05195
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Multiple Dose Study To Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP05195 in Healthy Adult Subjects

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • Assessment of safety & tolerability: adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination [ Time Frame: 17 days after drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DWP05195 Drug: DWP05195
tablets, oral administration, multiple administration
Other Name: DWP05195

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co.LTD.
ClinicalTrials.gov Identifier: NCT01094834     History of Changes
Other Study ID Numbers: DWP05195-P002
Study First Received: March 26, 2010
Last Updated: February 8, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on May 19, 2013