Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers
NCT ID: NCT01723891
Last Updated: 2012-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Surfolase capsule & HT-002-01
Surfolase capsule
HT-002-01
HT-002-01 & Surfolase capsule
Surfolase capsule
HT-002-01
Interventions
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Surfolase capsule
HT-002-01
Eligibility Criteria
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Inclusion Criteria
2. Volunteers without apriority of chronic disease
3. Volunteers must be in good health as determined by the investigator based on a detailed medical history, full physical examination, electrocardiogram, laboratory tests and urinalysis
4. Volunteers who comply with the protocol, understand and sign an informed consent
Exclusion Criteria
2. Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption
3. Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone
4. Known history of gastrointestinal disease which affects the absorption of medicine.
5. Excluded by screening tests
6. Upper limit of AST, ALT\>1.25 times Upper limit of total bilirubin\>1.5 times
7. Estimated GFR\<80mL/min/1.73m2)
8. systolic blood pressure \< 90 or \> 150, diastolic blood pressure \<50 or \>100
9. Known history of drug abuse
10. caffeine\>5cups/day, alcohol\>210g/week, 10 more cigarettes/day
11. Use of any prescription drug within 14days or over-the-counter (OTC) medication within 7 days prior to dosing
12. Participation in any clinical investigation within 60 days prior to study start
13. Donation of blood within 60 days, donation of component blood within 30days
14. Judged by the investigators to be undesirable as subjects
20 Years
55 Years
MALE
Yes
Sponsors
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Hyundai Pharmaceutical Co., LTD.
INDUSTRY
Responsible Party
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Locations
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Yonsei University Health System, Severance Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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HT-002-01
Identifier Type: -
Identifier Source: org_study_id