A Study to Compare PK, PD and Safety of the AD-214 and AD-2141

NCT05062876 | Completed Phase 1

• 1 other identifier: AD-214PK/PD-03
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 to AD-2141 in healthy volunteers.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

• AUCtau,ss(Area under the plasma drug concentration-time curve)

  Evaluateion PK Rabeprazole after multiple dose

  From Day 1 up to Day 29

• Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)

  Evaluation PD Rabeprazole after multiple dose

  Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring

Secondary Outcomes (17)

• AUCtau(Area under the plasma drug concentration-time curve)

  Day1

• Cmax(Maximum concentration of drug in plasma)

  Day1

• Tmax(Time to maximum plasma concentration)

  Day1

• t1/2(Terminal elimination half-life)

  Day1

• CL/F(Apparent clearance)

  Day1

Study Arms (2)

R-T

ACTIVE COMPARATOR

Period 1 : Test Drug(AD-214) Period 2 : Reference Drug(AD-2141)

Drug: AD-214; Drug: AD-2141

T-R

ACTIVE COMPARATOR

Period 1 : Reference Drug(AD-2141) Period 2 : Test Drug(AD-214)

Drug: AD-214; Drug: AD-2141

Interventions

AD-214 DRUG

1 tablet administered before the breakfast during 7 days

Also known as: Test drug

R-T; T-R

AD-2141 DRUG

1 tablet administered before the breakfast during 7 days

Also known as: Reference Drug

R-T; T-R

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Addpharma Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Seunghwan Lee, M.D.,Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: September 22, 2021
• First Posted: September 30, 2021
• Study Start: November 1, 2021
• Primary Completion: March 17, 2022
• Study Completion: March 29, 2022
• Last Updated: July 20, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)