A Clinical Trial to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers

ConditionBenign Prostatic Hyperplasia

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexMale

Age19+

SponsorAddpharma Inc.

About this trial

The study compare and evaluate the bioequivalence between the administration of AD-116A and the administration of AD-1161 in healthy adult male volunteers

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration

Other exclusions applied

Trial design

Design model

Crossover

Treatments tested in this trial

AD-116A
Drug
Oral Capsule
AD-1161
Drug
Oral Capsule

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: Sequence AExperimental treatment 2 interventions

Group B: Sequence BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Area under the plasma concentration-time curve during dosing interval (AUCt)

AUCt of AD-116A

Time frame

pre-dose (0hour) to 72hours

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-116A

Time frame

pre-dose (0hour) to 72hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Addpharma Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: