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

NCT06025773 | Completed Phase 1

• 1 other identifier: AD-212PK/PD-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)

  AUCτ,ss after 7days repeated administration of Lansoprazole

  pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)

• Percent Decrease from baseline of Integrated gastric acidity

  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

  24 hours before 1st administration to 24 hours after repeated administration (7days)

Study Arms (2)

Arm-A

EXPERIMENTAL

Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)

Drug: Lansoprazole 15 mg; Drug: Lansoprazole 15mg/Calcium carbonate 600mg

Arm-B

EXPERIMENTAL

Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)

Drug: Lansoprazole 15 mg; Drug: Lansoprazole 15mg/Calcium carbonate 600mg

Interventions

Lansoprazole 15 mg DRUG

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

Arm-A; Arm-B

Lansoprazole 15mg/Calcium carbonate 600mg DRUG

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

Arm-A; Arm-B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with trouble performing Gastric pH monitoring

Sponsors & Collaborators

• Addpharma Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Lansoprazole; Calcium Carbonate

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: September 15, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

KR (1)