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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R | Active Comparator |
| |
| T1 | Experimental |
| |
| T3 | Experimental |
| |
| T4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surfolase capsule (100mg) | Drug | Surfolase capsule one capsule twice one days fasting administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of ambroxol | blood serum sampling | |
| Cmax of ambroxol | blood serum sampling |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of ambroxol | blood serum sampling | |
| Tmax of ambroxol | blood serum sampling | |
| t1/2 of ambroxol |
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Inclusion Criteria:
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
Subject who don't have congenital or chronic diseases and have no abnormal medical examination results.
Subject is healthy (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
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:
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| Name | Affiliation | Role |
|---|---|---|
| Park | Yonsei University Health System, Severance Hospital | Principal Investigator |
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| Surfolase CR (200mg, T1) |
| Drug |
one tablet once one days fasting administration. |
|
| Surfolase CR (200mg, T3) | Drug | one tablet once one days fasting administration. |
|
| Surfolase CR (200mg, T4) | Drug | one tablet once one days fasting administration. |
|
| blood serum sampling |
| ID | Term |
|---|---|
| D014284 | Triiodothyronine |
| ID | Term |
|---|---|
| D013970 | Thyronines |
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013974 | Thyroxine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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