NCT02373891

Study to Evaluate the Effect of Food on the Pharmacokinetics of Surfolase CR Tablet in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hyundai Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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 Acebrophylline that intake twice daily 100mg to Surfolase CR that intake once daily 200mg

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Surfolase CR	T1: Surfolase CR (Acebrophylline 200mg) administration after fat intake Surfolase CR(Acebrophylline 200mg) administrated fasting or fat intake at D1 and D8 a.m. 8:00
DRUG	Surfolase CR	T0: Surfolase CR(Acebrophylline 200mg) fasting administration Surfolase CR(Acebrophylline 200mg) administrated fasting or fat intake at D1 and D8 a.m. 8:00

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-02-27
• Last updated: 2015-02-27