Clinical trial NCT02395913: Compare Safety and Pharmacokinetic Properties of Surfolase Capsule(Acebrophylline 100mg) and Surfolase CR(200mg)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male
Lead sponsor: Hyundai Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally administered as a salt composed of an acid-base as a compound that was synthesized by and chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state is allowed to recuperate or extended.

It was developed to improve compliance improve pharmaceutically Surfolase capsule(Acebrophylline 100mg) that intake twice daily 100mg to Surfolase CR(Acebrophylline 200mg) that intake once daily 200mg


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

Primary outcomes:
measure: AUCt of ambroxol
timeFrame: blood serum sampling
measure: Cmax of ambroxol
timeFrame: blood serum sampling
Secondary outcomes:
measure: AUCinf of ambroxol
timeFrame: blood serum sampling
measure: Tmax of ambroxol
timeFrame: blood serum sampling
measure: t1/2 of ambroxol
timeFrame: blood serum sampling
Other outcomes:
Locations:
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Park
role: PRINCIPAL_INVESTIGATOR
References: