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

Healthy Male Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395913
• Other study ID #: HT-002-02
• Status: Completed
• Phase: Phase 1
• First received: February 10, 2015
• Last updated: March 17, 2015
• Start date: July 2013
• Est. completion date: September 2013

Study information

• Verified date: March 2015
• Source: Hyundai Pharmaceutical Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Male

Intervention

Drug:
• Surfolase capsule (100mg)
Surfolase capsule one capsule twice one days fasting administration
• Surfolase CR (200mg, T1)
one tablet once one days fasting administration.
• Surfolase CR (200mg, T3)
one tablet once one days fasting administration.
• Surfolase CR (200mg, T4)
one tablet once one days fasting administration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hyundai Pharmaceutical Co., LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of ambroxol		blood serum sampling	No
Primary	Cmax of ambroxol		blood serum sampling	No
Secondary	AUCinf of ambroxol		blood serum sampling	No
Secondary	Tmax of ambroxol		blood serum sampling
Secondary	t1/2 of ambroxol		blood serum sampling