A Clinical Trial to Evaluate the Safety and the Pharmacokinetics of AD-116 Compared to AD-1161 in Healthy Adult Male Volunteers
Not Applicable
Not yet recruiting
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Drug: AD-116Drug: AD-1161
- Registration Number
- NCT07103278
- Lead Sponsor
- Addpharma Inc.
- Brief Summary
The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-116 and the administration of AD-1161 in healthy adult male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A AD-116 Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116) Sequence A AD-1161 Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116) Sequence B AD-116 Period 1 : Test Drug(AD-116), Period 2 : Reference Drug(AD-1161) Sequence B AD-1161 Period 1 : Test Drug(AD-116), Period 2 : Reference Drug(AD-1161)
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve during dosing interval (AUCt) pre-dose (0hour) to 72hours AUCt of AD-116
Maximum concentration of drug in plasma (Cmax) pre-dose (0hour) to 72hours Cmax of AD-116
- Secondary Outcome Measures
Name Time Method