A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121

A Randomized, Open-label, 2x2 Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of AD-212-A or AD-2121 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06025773

Enrollment

Registered

2023-09-06

Start date

2023-09-15

Completion date

2024-04-19

Last updated

2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Esophageal Reflux

Brief summary

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.

Detailed description

The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-212-A compared with AD-2121 in healthy subjects.

Interventions

DRUGLansoprazole 15 mg

AD-2121 (Lansoprazole 15 mg), Oral, Capsule

DRUGLansoprazole 15mg/Calcium carbonate 600mg

AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit * The Age equal to or greater than 19 in healthy volunteers at the time of screening visit * Negative result from Serum Helicobacter pylori antibody at the time of screening visit

Exclusion criteria

* Patients with trouble performing Gastric pH monitoring

Design outcomes

Primary

Measure	Time frame	Description
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)	pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)	AUCτ,ss after 7days repeated administration of Lansoprazole
Percent Decrease from baseline of Integrated gastric acidity	24 hours before 1st administration to 24 hours after repeated administration (7days)	Percent Decrease from baseline of Integrated gastric acidity after repeated adadministration of Lansoprazole Integrated gastric acidity calculation: (Integrated gastric acidity Before - Integrated gastric acidity after)/Integrated gastric acidity Before\100 Acid concentration (mM) = 1000 ⅹ 10-pH * Acidity (mmol.h/L) = (acid in mM at time 't' + acid in mM at time 't-1')/2 ⅹ (t-(t-1)) * Integrated Acidity means cumulative sum per second for 24 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026