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

Phase 1

Completed

• Conditions: Gastro Esophageal Reflux
• Interventions: Drug: Lansoprazole 15 mg; Drug: Lansoprazole 15mg/Calcium carbonate 600mg

• Registration Number: NCT06025773
• Lead Sponsor: Addpharma Inc.

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.

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-03
• Study First Posted: 2023-09-06
• Study Start: 2023-09-15
• Primary Completion: 2024-04-19
• Study Completion: 2024-04-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

• Patients with trouble performing Gastric pH monitoring

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm-B	Lansoprazole 15 mg	Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)
Arm-A	Lansoprazole 15mg/Calcium carbonate 600mg	Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)
Arm-A	Lansoprazole 15 mg	Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)
Arm-B	Lansoprazole 15mg/Calcium carbonate 600mg	Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of