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

Sponsor
Addpharma Inc.
Study ID
NCT07722871
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

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

Key Dates

First listed
Jul 23, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

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

Primary Outcome Measure

1. Area under the plasma concentration-time curve during dosing interval (AUCt) [ Time Frame: [Time Frame: pre-dose (0hour) to 48hours] ]

Central Contacts

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