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

Sponsor
Addpharma Inc.
Study ID
NCT07444385
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 26, 2026
Status verified
Mar 2026
Primary completion
Apr 22, 2026
Completion
May 8, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence A
    Period 1 : Reference Drug(Duodart capsule), Period 2 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg) Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2.
  • Experimental: Sequence B
    Period 1 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg), Period 2 : Reference Drug(Duodart capsule) ) Single-dose oral administration of AD-116 (Duodart capsule) in Period 1, followed by single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 2.

Primary Outcome Measure

Area under the plasma concentration-time curve during dosing interval (AUCt) [ Time Frame: pre-dose (0hour) to 72hours ]

Central Contacts

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