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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02395913
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hyundai Pharmaceutical Co., LTD.

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


Condition or disease Intervention/treatment Phase
Healthy Male Drug: Surfolase capsule (100mg) Drug: Surfolase CR (200mg, T1) Drug: Surfolase CR (200mg, T3) Drug: Surfolase CR (200mg, T4) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Active Comparator: R Drug: Surfolase capsule (100mg)
Surfolase capsule one capsule twice one days fasting administration

Experimental: T1 Drug: Surfolase CR (200mg, T1)
one tablet once one days fasting administration.

Experimental: T3 Drug: Surfolase CR (200mg, T3)
one tablet once one days fasting administration.

Experimental: T4 Drug: Surfolase CR (200mg, T4)
one tablet once one days fasting administration.




Primary Outcome Measures :
  1. AUCt of ambroxol [ Time Frame: blood serum sampling ]
  2. Cmax of ambroxol [ Time Frame: blood serum sampling ]

Secondary Outcome Measures :
  1. AUCinf of ambroxol [ Time Frame: blood serum sampling ]
  2. Tmax of ambroxol [ Time Frame: blood serum sampling ]
  3. t1/2 of ambroxol [ Time Frame: blood serum sampling ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395913


Sponsors and Collaborators
Hyundai Pharmaceutical Co., LTD.
Investigators
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Principal Investigator: Park Yonsei University Health System, Severance Hospital
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Responsible Party: Hyundai Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT02395913    
Other Study ID Numbers: HT-002-02
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015