Efficacy and Safety of HCP1102 Capsule

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

Inclusion:

• Age≥15

• Mild or moderate asthma patients with allergic rhinitis

• Patient who meet all criteria of rhinitis

• Patients understood the contents and purpose of this trial and signed informed consent form

• Patients who are capable and willing to write subject diary

• Patients who agree with maintain same environment during clinical trials

Exclusion:

• Nonallergic rhinitis

• Severe asthma

• Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma

• Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety

• Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption

• Alcohol abuse or Drug abuse

• Genetic factor of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption

• pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives

• Patient who administered other investigational products within 30 days

• Current smoker Judged to be inappropriate for the study by the investigator after reviewing other reasons