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

Sponsor

Addpharma Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06025773

Collaborator

(none)

Enrollment

Arms

2.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastro Esophageal Reflux	Drug: Lansoprazole 15 mg Drug: Lansoprazole 15mg/Calcium carbonate 600mg	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 8, 2023

Anticipated Primary Completion Date :

Nov 14, 2023

Anticipated Study Completion Date :

Nov 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm-A Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)	Drug: Lansoprazole 15 mg AD-2121 (Lansoprazole 15 mg), Oral, Capsule Drug: Lansoprazole 15mg/Calcium carbonate 600mg AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet
Experimental: Arm-B Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)	Drug: Lansoprazole 15 mg AD-2121 (Lansoprazole 15 mg), Oral, Capsule Drug: Lansoprazole 15mg/Calcium carbonate 600mg AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet

Arm

Intervention/Treatment

Experimental: Arm-A

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

Drug: Lansoprazole 15 mg

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

Drug: Lansoprazole 15mg/Calcium carbonate 600mg

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

Experimental: Arm-B

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

Drug: Lansoprazole 15 mg

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

Drug: Lansoprazole 15mg/Calcium carbonate 600mg

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Addpharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Addpharma Inc.

ClinicalTrials.gov Identifier:

NCT06025773

Other Study ID Numbers:

AD-212PK/PD-03

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 6, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastroesophageal Reflux

Study Results

No Results Posted as of Sep 6, 2023