A Study to Compare to PK Characteristics and Safety Profiles Between AD-117 and AD-117A
Not Applicable
Not yet recruiting
- Conditions
- Mixed Dyslipidemia
- Interventions
- Drug: AD-117Drug: AD-117A
- Registration Number
- NCT07152873
- Lead Sponsor
- Addpharma Inc.
- Brief Summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-117 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
Exclusion Criteria
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A (RT) AD-117 Period 1: Reference (AD-117A), Period 2: Test (AD-117) Sequence A (RT) AD-117A Period 1: Reference (AD-117A), Period 2: Test (AD-117) Sequence B (TR) AD-117 Period 1: Test (AD-117), Period 2: Reference (AD-117A) Sequence B (TR) AD-117A Period 1: Test (AD-117), Period 2: Reference (AD-117A)
- Primary Outcome Measures
Name Time Method Maximum concentration of drug in plasma (Cmax) pre-dose (0hour) to 72hours Cmax of AD-117
Area under the plasma concentration-time curve during dosing interval (AUCt) pre-dose (0hour) to 72hours AUCt of AD-117
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H Plus Yangji Hospital
🇰🇷Seoul, South Korea
H Plus Yangji Hospital🇰🇷Seoul, South Korea