A Study to Evaluate the Safety, Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult Subjects | NCT07717749

NCT07717749

Overview

NCT ID: NCT07717749
Lead Sponsor: Addpharma Inc.INDUSTRY
Official Title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-118 Compared to AD-1181 in Healthy Adult Volunteers
Brief Summary: A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult Subjects
Conditions: Chronic Heart Failure
Interventions: AD-118, AD-1181
AD-118, AD-1181

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Jul 24, 2026Estimated
Primary Completion Date: Aug 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Subjects aged 19 years or older and under 65 years at the screening visit

Exclusion Criteria:

Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration

Other exclusions applied

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 74Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: JaeHun JungContact
jhjung@addpharma.co.kr+82-31-891-5683

Similar Studies

Participant Group/Arms

Sequence AExperimental

Period 1 : Reference drug(AD-1181), Period 2 : Test drug(AD-118) Single-dose oral administration of AD-1181 in Period 1, followed by single-dose oral administration of AD-118 in Period 2.

Drug: AD-118, AD-1181

Sequence BExperimental

Period 1 : Test drug(AD-118), Period 2 : Reference drug(AD-1181) Single-dose oral administration of AD-118 in Period 1, followed by single-dose oral administration of AD-1181 in Period 2.

Drug: AD-118, AD-1181