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Not yet recruiting NCT07722871

A Clinical Trial to Evaluate the Bioequivalence of AD-116A and AD-1161 Under Fed Conditions in Healthy Adult Male Volunteers

Phase I Interventional Benign Prostatic Hyperplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AD-116A, AD-1161.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 19 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions

Overview

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

Interventions

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

Primary outcome measures

  • 1. Area under the plasma concentration-time curve during dosing interval (AUCt) [Time frame: [Time Frame: pre-dose (0hour) to 48hours]]
Secondary outcome measures (1)
  • 2. Maximum concentration of drug in plasma (Cmax) [Time frame: [Time Frame: pre-dose (0hour) to 48hours]]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Participation in another clinical study with an investigational drug within 6 months prior to the scheduled first administration
  • Other exclusions applied

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • H PLUS YANGJI HOSPITAL, Seoul — Seoul

Identifiers

NCT: NCT07722871 · AD-116FED-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗