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

Gastro Esophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025773
• Other study ID #: AD-212PK/PD-03
• Status: Recruiting
• Phase: Phase 1
• Start date: September 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: January 2024
• Source: Addpharma Inc.
• Contact: Jeong Eun Park
• Phone: +82-31-891-6989
• Email: parkje[@]addpharma.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Drug:
• Lansoprazole 15 mg
AD-2121 (Lansoprazole 15 mg), Oral, Capsule
• Lansoprazole 15mg/Calcium carbonate 600mg
AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve over a dosing interval at steady state (AUCt,ss)	AUCt,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)
Primary	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 ? 10-pH; Acidity (mmol.h/L) = (acid in mM at time 't' + acid in mM at time 't-1')/2 ? (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)