A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects

ConditionBenign Prostatic Hyperplasia

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexMale

Age19+

SponsorAddpharma Inc.

About this trial

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects

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-116, AD-1161
Drug
Single-dose oral administration of AD-116 or AD-1161, according to randomized sequence.

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: Sequence AExperimental treatment 1 intervention

Group B: Sequence BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

AUCt of AD-116

Time frame

pre-dose (0hour) to 72hours

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-116

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

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