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

Sponsor
Addpharma Inc.
Study ID
NCT07103278
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-116 and the administration of AD-1161 in healthy adult male volunteers

Key Dates

Start date
Dec 31, 2025
Status verified
Sep 2025
Primary completion
Jan 31, 2026
Completion
Jan 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-116)
  • Experimental: Sequence B
    Period 1 : Test Drug(AD-116), 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 ]

Related Studies