A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole

• Sponsor: Addpharma Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04622358
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 14.1

Study Details

Study Description

Brief Summary

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214-02 to Rabeprazole in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: AD-214-02; Drug: Rabeprazole	Phase 1

Detailed Description

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214-02 compared with administration of Rabeprazole in healthy volunteers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214-02 to Rabeprazole in Healthy Volunteers
• Actual Study Start Date: Dec 5, 2020
• Actual Primary Completion Date: Mar 8, 2021
• Actual Study Completion Date: Mar 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AD-214-02/Rabeprazole Period 1 : Test Drug(AD-214-02) Period 2 : Reference Drug(Rabeprazole)	Drug: AD-214-02; 1 tablet administered before the breakfast during 7 days; Drug: Rabeprazole; 1 tablet administered before the breakfast during 7 days
Experimental: Rabeprazole/AD-214 Period 1 : Reference Drug(Rabeprazole) Period 2 : Test Drug(AD-214-02)	Drug: AD-214-02; 1 tablet administered before the breakfast during 7 days; Drug: Rabeprazole; 1 tablet administered before the breakfast during 7 days

Outcome Measures

Primary Outcome Measures

1. AUCtau,ss(Area under the plasma drug concentration-time curve) [From Day 1 up to Day 29]

   Evaluation PK Rabeprazole after multiple dose

2. Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity) [Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring]

   Evaluation PD Rabeprazole after multiple dose

Secondary Outcome Measures

1. AUCtau(Area under the plasma drug concentration-time curve) [Day1]

   Evaluation PK Rabeprazole after single dose

2. Cmax(Maximum concentration of drug in plasma) [Day1]

   Evaluation PK Rabeprazole after single dose

3. Tmax(Time to maximum plasma concentration) [Day1]

   Evaluation PK Rabeprazole after single dose

4. t1/2(Terminal elimination half-life) [Day1]

   Evaluation PK Rabeprazole after single dose

5. Cmax,ss(Maximum concentration of drug in plasma at steady state) [From Day 1 up to Day 29]

   Evaluation PK Rabeprazole after multiple dose

6. Tmax,ss(Time to maximum plasma concentration at steady state) [From Day 1 up to Day 29]

   Evaluation PK Rabeprazole after multiple dose

7. t1/2,ss(Terminal elimination half-life at steady state) [From Day 1 up to Day 29]

   Evaluation PK Rabeprazole after multiple dose

8. After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours [Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring]

   Evaluation PD Rabeoprazoke

9. After the first administration and 7 days of repeated administration, The median pH measured for 24 hours [Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring]

   Evaluation PD Rabeoprazoke

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 19~50 years in healthy volunteers

• BMI is more than 18.0 kg/m^{2 , no more than 27.0 kg/m}2

• Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system

• Subjects who judged ineligible by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Addpharma Inc.

Investigators

• Principal Investigator: Seunghwan Lee, M.D.,Ph.D, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Addpharma Inc.
• ClinicalTrials.gov Identifier: NCT04622358
• Other Study ID Numbers: AD-214PK/PD-02
• First Posted: Nov 10, 2020
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroesophageal Reflux; Rabeprazole

Study Results

No Results Posted as of Jul 21, 2021