Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers | NCT01723891 | Trialant
CompletedInterventionalPhase 1Updated Nov 8, 2012
Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers
ClinicalTrials.gov ID
NCT01723891
Lead Sponsor
Hyundai Pharmaceutical Co., LTD.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
24Actual
Last Update Posted
Nov 8, 2012Estimated
Start Date
Nov 2012
Brief Summary
Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer.
Healthy
Surfolase capsule
HT-002-01
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25
Volunteers without apriority of chronic disease
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
Volunteers who comply with the protocol, understand and sign an informed consent
Exclusion Criteria:
Sensitive response to acebrophylline and xanthine
Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption
Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone
Known history of gastrointestinal disease which affects the absorption of medicine.
Excluded by screening tests
Upper limit of AST, ALT>1.25 times Upper limit of total bilirubin>1.5 times
Estimated GFR<80mL/min/1.73m2)
systolic blood pressure < 90 or > 150, diastolic blood pressure <50 or >100
Known history of drug abuse
caffeine>5cups/day, alcohol>210g/week, 10 more cigarettes/day
Use of any prescription drug within 14days or over-the-counter (OTC) medication within 7 days prior to dosing
Participation in any clinical investigation within 60 days prior to study start
Donation of blood within 60 days, donation of component blood within 30days
Judged by the investigators to be undesirable as subjects
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Yonsei University Health System, Severance Hospital