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

Sponsor
Addpharma Inc.
Study ID
NCT07715305
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • AD-116A — DRUG
    Oral Capsule
  • AD-1161 — DRUG
    Oral Capsule

Study Details

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

Key Dates

First listed
Jul 20, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

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

Arms

  • Experimental: Sequence A
    Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116A)
  • Experimental: Sequence B
    Period 1 : Test Drug(AD-116A), Period 2 : Reference Drug(AD-1161)

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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