Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
20 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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