Food Effect Study of AD-117, Mixed Dyslipidemia
Conditions
Brief summary
A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers
Detailed description
An open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the food effect on the safety and the pharmacokinetics of AD-117 in healthy adult volunteers
Interventions
DRUGAD-117
AD-117 1Tab., Per Oral
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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 * Healthy volunteers aged ≥19 and \<65 years 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration of drug in plasma (Cmax) | 0-72 hours | Cmax of AD-117 |
| Area under the plasma concentration-time curve during dosing interval (AUCt) | 0-72 hours | AUCt of AD-117 |
Countries
South Korea
Outcome results
None listed