A Study of Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234,... | NCT07717775

NCT07717775

Overview

NCT ID: NCT07717775
Lead Sponsor: Addpharma Inc.INDUSTRY
Official Title: A Randomized, Open-label, 6-sequence, 3-period Crossover Clinical Trial to Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adult Volunteers.
Brief Summary: Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-234, AD-2341, AD-2342 in healthy subjects.
Conditions: Gastritis
Interventions: AD-234
AD-2341
AD-2342

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

Healthy adult volunteers aged 19 to 50 years, inclusive, at the time of screening

Body weight between 50.0 kg and 90.0 kg, inclusive, and body mass index (BMI) between 18.5 kg/m^2 and 29.9 kg/m^2, inclusive, at the time of screening (BMI = weight [kg] / height [m]^2)

For female participants: not pregnant, not breastfeeding, or surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)

Exclusion Criteria:

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

Participant Group/Arms

Arm A(Vonoprazan, Fexuprazan, Vonoprazan)Experimental

Participants receive AD-234 - AD-2341-AD-2342

Drug: AD-234

Drug: AD-2341

Drug: AD-2342

Arm B(Vonoprazan, Vonoprazan, Fexuprazan)Experimental

Participants receive AD-234 - AD-2342- AD-2341

Drug: AD-234

Arm C(Fexuprazan, Vonoprazan, Vonoprazan)Experimental

Participants receive AD-2341-AD-234-AD-2342

Drug: AD-234

Arm D(Fexuprazan, Vonoprazan, Vonoprazan)Experimental

Participants receive AD-2341-AD-2342-AD-234

Drug: AD-234

Arm E(Vonoprazan, Vonoprazan, Fexuprazan)Experimental

Participants receive AD-2342 -AD-234-AD-2341

Drug: AD-234

Arm F(Vonoprazan, Fexuprazan, Vonoprazan)Experimental

Participants receive AD-2342-AD-2341-AD-234

Drug: AD-234