An open-label, randomized, single-dose, 2way crossover study to compare the pharmacokinetics of Traclear 62.5 mg 2 tablets and HGP1206 125 mg 1 tablet in healthy male volunteers
Not Applicable
Recruiting
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0000802
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 28
Inclusion Criteria
1.Healthy male volunteers, age 20 to 55 years.
2.The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
Exclusion Criteria
1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Hypersensitive reactions to traclear, or other drugs (aspirin, antibiotics ect.) or, history of clinically significant hypersensitive reactions
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax;AUC last
- Secondary Outcome Measures
Name Time Method AUCinf