Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: TALION®Drug: DA-5206(Fasting)Drug: DA-5206(Fed)
- Registration Number
- NCT03200496
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- Healthy male volunteer 19 years to 45 years
- Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg
- The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate
Exclusion Criteria
- Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with acute disease within 28 days before the first dose of Investigational product
- Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
- Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TALION® TALION® - DA-5206(Fasting) DA-5206(Fasting) - DA-5206(Fed) DA-5206(Fed) -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) 0~24hr PK Parameter
Peak Plasma Concentration (Cmax) 0~24hr PK Parameter
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of