A Randomized, Open-label, Single-dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-115A and the Administration of AD-1151 for Healthy Subjects in Fasting State
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
• Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
Locations
Other Locations
Republic of Korea
H PLUS YANGJI HOSPITAL, Seoul
RECRUITING
Seoul
Contact Information
Primary
JaeHun Jung
jhjung@addpharma.co.kr
+82-31-891-5683
Time Frame
Start Date: 2026-01-27
Estimated Completion Date: 2026-03-16
Participants
Target number of participants: 46
Treatments
Experimental: Sequence A
Period 1 : Reference Drug(Rebanex Tab), Period 2 : Test Drug(Revaprazan sulfate)~Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2.
Experimental: Sequence B
Period 1 : Test Drug(Revaprazan sulfate), Period 2 : Reference Drug(Rebanex Tab)~Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2.
Related Therapeutic Areas
Sponsors
Leads: Addpharma Inc.