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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01094834
Other study ID # DWP05195-P002
Secondary ID
Status Completed
Phase Phase 1
First received March 26, 2010
Last updated February 8, 2011
Start date April 2010

Study information

Verified date February 2011
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Drug:
DWP05195
tablets, oral administration, multiple administration

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of safety & tolerability: adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination 17 days after drug administration No
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