Pharmacokinetics and Safety Profiles After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteers
- Registration Number
- NCT05132049
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
Pharmacokinetics and safety Profiles after administration of DA-5211 and co-administration of DA-5211-R1 and DA-5211-R2 in healthy adult volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Healthy volunteers
- BMI between 18 and 30 kg/m2
- Body weight: Male≥50kg, Female≥45kg
- Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study
Exclusion Criteria
- Subjects with allergy or drug hypersensitivity
- Subjects with clinically significant medical history
- Subjects with history of drug abuse or addicted
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence B DA-5211-R1 + DA-5211-R2 - Sequence A DA-5211 - Sequence A DA-5211-R1 + DA-5211-R2 - Sequence B DA-5211 -
- Primary Outcome Measures
Name Time Method AUCt pre-dose~72 hours post-dose area under the curve
Cmax pre-dose~72 hours post-dose maximum plasma concentration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bumin Hospital
🇰🇷Seoul, Korea, Republic of