Benign Prostatic Hyperplasia
Conditions
Brief summary
The study compare and evaluate the bioequivalence between the administration of AD-116A and the administration of AD-1161 in healthy adult male volunteers
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body weight equal to or greater than 50kg 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 adult male 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve during dosing interval (AUCt) | pre-dose (0hour) to 72hours | AUCt of AD-116A |
| Maximum concentration of drug in plasma (Cmax) | pre-dose (0hour) to 72hours | Cmax of AD-116A |
Countries
South Korea
Contacts
CONTACTSoyoung Hwang
Outcome results
None listed