Compare Safety and Pharmacokinetic Properties of Surfolase Capsule(Acebrophylline 100mg) and Surfolase CR(200mg)

Launched by HYUNDAI PHARMACEUTICAL CO., LTD. · Mar 17, 2015

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male subjects between the ages of 20 and 55 years, BMI \>18.5, \<25, inclusive
• • \*Body mass index (kg/m2) = weight(kg)/height(m)2
• • 2. Subject who don't have congenital or chronic diseases and have no abnormal medical examination results.
• • 3. Subject is healthy (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
• • 4. Subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study
• Exclusion Criteria:
• • 1. Subject with known for hypersensitivity reaction to acebrophylline, xanthine and food.
• • 2. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• • 3. Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
• • 4. Subject with known for history of gastrointestinal disease or gastrointestinal surgery which affect on the absorption drug
• • 5. Subjects with any of the following condition in screening (blood pressure, 12-lead ECG, blood, urinalysis, etc.)
• • 6. Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) \> Upper normal limit × 1.25 ii. Total bilirubin \> Upper normal limit × 1.5
• • 7. If the estimated GFR \< 80mL/min/1.76m2 using MDRD formula.
• • 8. Systolic blood pressure \<=90mmHg or diastolic blood pressure \>=150mmHg or a person showing the corresponding figures \<=50mmHg or \>=100mmHg in vital signs.
• • 9. Who has history of drug abuse (especially hypnotic, central acting analgesics, psychotropic drugs, such as opiates or central nervous system acting drug) or shows positive reactions to drug of abuse in urine drug screening tests.
• • 10. Excessive caffeine and alcohol intake, smoking person(caffeine: \> 5cups/day, alcohol: \>210g/week, tobacco: \> 10 cagarettes/day)
• • 11. Use of any prescription medication within 14 days prior to study medication dosing or use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
• • 12. Participation in any clinical investigation within 60days prior to study medication dosing
• • 13. Subjects with whole blood donation within 60days, component blood donation within 30days
• • 14. Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator