A Clinical Trial to Evaluate the Bioequivalence of AD-116A and AD-1161 Under Fed Conditions 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

This study compares and evaluates the bioequivalence of AD-116A and AD-1161 in healthy adult male volunteers under fed conditions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body weight equal to or greater than 50 kg and body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Age equal to or greater than 19 years in healthy adult male volunteers at the time of screening visit

Disqualifiers

Participation in another clinical study with an investigational drug within 6 months prior to the 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 A(RT)Experimental treatment 2 interventions

Group B: Sequence B(TR)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

AUCt of AD-116A

Time frame

[Time Frame: pre-dose (0hour) to 48hours]

Secondary outcomes

2. Maximum concentration of drug in plasma (Cmax)

Cmax of AD-116A

Time frame

[Time Frame: pre-dose (0hour) to 48hours]

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: