A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole

NCT03980756 | Completed Phase 1

• 1 other identifier: AD-206PK/PD
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.

Conditions

Gastritis

Outcome Measures

Primary Outcomes (2)

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

  Evaluation PK esomeprazole 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 esomeprazole after multiple dose

  Day1 24hrs pH monitoring, Day7 24hrs 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 (4)

Group A1

EXPERIMENTAL

Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)

Drug: AD-206 20mg; Drug: Esomeprazole 20mg

Group A2

EXPERIMENTAL

Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)

Drug: AD-206 20mg; Drug: Esomeprazole 20mg

Group B1

EXPERIMENTAL

Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)

Drug: AD-206 40mg; Drug: Esomeprazole 40mg

Group B2

EXPERIMENTAL

Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)

Drug: AD-206 40mg; Drug: Esomeprazole 40mg

Interventions

AD-206 20mg DRUG

1 tablet administered before the breakfast during 7 days

Also known as: Test drug

Group A1; Group A2

Esomeprazole 20mg DRUG

1 tablet administered before the breakfast during 7 days

Also known as: Reference Drug

Group A1; Group A2

AD-206 40mg DRUG

1 tablet administered before the breakfast during 7 days

Also known as: Test drug

Group B1; Group B2

Esomeprazole 40mg DRUG

1 tablet administered before the breakfast during 7 days

Also known as: Reference Drug

Group B1; Group B2

Eligibility Criteria

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

You may qualify if:

• Age 19\~50 years in healthy male volunteers
• BMI is more than 18 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

Gastritis

Interventions

Drug Evaluation; Esomeprazole

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• In-Jin Jang, 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: June 4, 2019
• First Posted: June 10, 2019
• Study Start: June 5, 2019
• Primary Completion: April 27, 2020
• Study Completion: June 18, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)