Study to Evaluate the Effect of Food on the Pharmacokinetics of Surfolase CR Tablet in Healthy Volunteers
Study to Evaluate the Effect of Food on the Pharmacokinetics of Surfolase CR Tablet in Healthy Volunteers
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 Acebrophylline that intake
 twice daily 100mg to Surfolase CR that intake once daily 200mg
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

 -  Hematology tests: WBC with differential count, RBC, Hemoglobin, Hematocrit,
 Platelet, PT(INR)/aPTT

 -  Blood chemistry tests: Calcium, Inorganic Phosphate, Fasting Glucose, BUN,
 Creatinine, Cholesterol, Total Protein, Albumin, Total Bilirubin, Alkaline
 phosphatase, AST, ALT, r-GT, LDH, TG, K, Na, Cl, uric acid, CPK

 -  Immune serum tests: HBsAg, anti-HCV Ab, anti-HIV Ag/Ab, β-hCG

 -  Urinalysis: Specific Gravity, pH, Protein, Glucose, Ketone, RBC, Urobilinogen,
 Bilirubin, Nitrite, WBC, Color, Turbidity, Sediment, Microscopy

 -  Urine drug screening tests: Amphetamine, Barbiturate, Morphine, Benzodiazepine,
 Cocaine 4) If you are a woman, you must be a negative pregnancy test at
 screening.

 -  Postmenopausal (no period for at least two years)

 -  Surgical sterilization (Hysterectomy or bilateral oophorectomy, tubal ligation)

 -  Before the screening, interfile male partner and this man is the sole partner of
 that person

 -  Before Investigational product first dose administered at least 14 days before
 the start appropriate contraception until at least 28 days.

 5) If you are a male and sexually active women of childbearing age, during the
 trial period contraception (condoms, etc.) and clinical trial duration, and IND
 maintaining adequate contraception up to 28 days after the last dose, and one
 party must agree that you will not donate sperm 6) 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

 -  AST or ALT > Upper normal limit × 1.25

 -  Total bilirubin > Upper normal limit × 1.5

 7. If the estimated GFR < 80mL/min/1.73m2 using MDRD formula.

 ※ MDRD equation (mL/min/1.73m2)

 : GFR = 175 x Scr-1.154 x age-0.203

 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. Person cannot be non-smoking, non-alcohol during the hospital stay.

 12. 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

 13. Participation in any clinical investigation within 60days prior to study medication
 dosing

 14. Subjects with whole blood donation within 60days, component blood donation within
 30days

 15. Women who are pregnant or breast-feeding

 16. Person who cannot eat, including high-fat diet (more than 900kcal, containing more
 that 35% fat) that served during the trial period

 17. Person can not prohibit the consumption of grapefruit-containing food during the trial
 period.

 18. 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