GastritisPhase 1NCT03980756
A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole
A Phase 1 study testing AD-206 20mg, Esomeprazole 20mg and AD-206 40mg in people with Gastritis, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastritis
- What is being tested?
- AD-206 20mg, Esomeprazole 20mg and AD-206 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jun 2019to 18 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.
Read the detailed description
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.
- Conditions
- Gastritis
- Being tested
- AD-206 20mg, Esomeprazole 20mg, AD-206 40mg, Esomeprazole 40mg
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-206 20mgDrug
Also called Test drug
1 tablet administered before the breakfast during 7 days
Esomeprazole 20mgDrug
Also called Reference Drug
1 tablet administered before the breakfast during 7 days
AD-206 40mgDrug
Also called Test drug
1 tablet administered before the breakfast during 7 days
Esomeprazole 40mgDrug
Also called Reference Drug
1 tablet administered before the breakfast during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Experimental | Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg) Receives: Drug: AD-206 20mg; Drug: Esomeprazole 20mg |
| Group A2 | Experimental | Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg) Receives: Drug: AD-206 20mg; Drug: Esomeprazole 20mg |
| Group B1 | Experimental | Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg) Receives: Drug: AD-206 40mg; Drug: Esomeprazole 40mg |
| Group B2 | Experimental | Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg) Receives: Drug: AD-206 40mg; Drug: Esomeprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau,ss(Area under the plasma drug concentration-time curve)
Evaluation PK esomeprazole after multiple dose
Measured: 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
Measured: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Secondary outcomes (17)
AUCtau(Area under the plasma drug concentration-time curve)
Evaluation PK esomeprazole after single dose
Measured: Day1
Cmax(Maximum concentration of drug in plasma)
Evaluation PK esomeprazole after single dose
Measured: Day1
Tmax(Time to maximum plasma concentration)
Evaluation PK esomeprazole after single dose
Measured: Day1
t1/2(Terminal elimination half-life)
Evaluation PK esomeprazole after single dose
Measured: Day1
CL/F(Apparent clearance)
Evaluation PK esomeprazole after single dose
Measured: Day1
Vd/F(Apparent volume of distribution)
Evaluation PK esomeprazole after single dose
Measured: Day1
Cmax,ss(Maximum concentration of drug in plasma at steady state)
Evaluation PK esomeprazole after multiple dose
Measured: From Day 1 up to Day 29
Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)
Evaluation PK esomeprazole after multiple dose
Measured: From Day 1 up to Day 29
Cav,ss(Average concentration of drug in plasma at steady state)
Evaluation PK esomeprazole after multiple dose
Measured: From Day 1 up to Day 29
Tmax,ss(Time to maximum plasma concentration at steady state)
Evaluation PK esomeprazole after multiple dose
Measured: From Day 1 up to Day 29
t1/2,ss(Terminal elimination half-life at steady state)
Evaluation PK esomeprazole after multiple dose
Measured: From Day 1 up to Day 29
CLss/F(Apparent Clearance at steady state)
Evaluation PK esomeprazole after multiple dose
Measured: From Day 1 up to Day 29
Vss/F(Apparent Volume of distribution at steady state)
Evaluation PK esomeprazole after multiple dose
Measured: From Day 1 up to Day 29
PTF(Peak trough fluctuation over one dosing interal at steady state)
Evaluation PK esomeprazole after multiple dose
Measured: From Day 1 up to Day 29
After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours
Evaluation PD esomeprazole
Measured: Day1 24hrs pH monitoring
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
Evaluation PD esomeprazole
Measured: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Evaluation PD esomeprazole
Measured: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start5 Jun 2019
- Primary completion27 Apr 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, M.D.,Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980756
- Sponsor's protocol ID
- AD-206PK/PD
- Status last verified
- Jan 2021
- First submitted
- 4 Jun 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03980756
- Acronym / sponsor ID
- AD-206PK/PD
- Conditions
- Gastritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.
Detailed description
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A1 | Experimental | Drug: AD-206 20mg, Drug: Esomeprazole 20mgPeriod 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg) |
| Group A2 | Experimental | Drug: AD-206 20mg, Drug: Esomeprazole 20mgPeriod 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg) |
| Group B1 | Experimental | Drug: AD-206 40mg, Drug: Esomeprazole 40mgPeriod 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg) |
| Group B2 | Experimental | Drug: AD-206 40mg, Drug: Esomeprazole 40mgPeriod 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD-206 20mgAlso: Test drug1 tablet administered before the breakfast during 7 days | Drug | Group A1, Group A2 |
| Esomeprazole 20mgAlso: Reference Drug1 tablet administered before the breakfast during 7 days | Drug | Group A1, Group A2 |
| AD-206 40mgAlso: Test drug1 tablet administered before the breakfast during 7 days | Drug | Group B1, Group B2 |
| Esomeprazole 40mgAlso: Reference Drug1 tablet administered before the breakfast during 7 days | Drug | Group B1, Group B2 |
Primary outcome
AUCtau,ss(Area under the plasma drug concentration-time curve)
Time frame: From Day 1 up to Day 29
Evaluation PK esomeprazole after multiple dose
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Evaluation PD esomeprazole after multiple dose
17 secondary outcomes
AUCtau(Area under the plasma drug concentration-time curve)
Time frame: Day1
Cmax(Maximum concentration of drug in plasma)
Time frame: Day1
Tmax(Time to maximum plasma concentration)
Time frame: Day1
t1/2(Terminal elimination half-life)
Time frame: Day1
CL/F(Apparent clearance)
Time frame: Day1
Vd/F(Apparent volume of distribution)
Time frame: Day1
Cmax,ss(Maximum concentration of drug in plasma at steady state)
Time frame: From Day 1 up to Day 29
Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)
Time frame: From Day 1 up to Day 29
Cav,ss(Average concentration of drug in plasma at steady state)
Time frame: From Day 1 up to Day 29
Tmax,ss(Time to maximum plasma concentration at steady state)
Time frame: From Day 1 up to Day 29
t1/2,ss(Terminal elimination half-life at steady state)
Time frame: From Day 1 up to Day 29
CLss/F(Apparent Clearance at steady state)
Time frame: From Day 1 up to Day 29
Vss/F(Apparent Volume of distribution at steady state)
Time frame: From Day 1 up to Day 29
PTF(Peak trough fluctuation over one dosing interal at steady state)
Time frame: From Day 1 up to Day 29
After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours
Time frame: Day1 24hrs pH monitoring
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang, M.D.,Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AD-206 20mg, Esomeprazole 20mg and AD-206 40mg in people with Gastritis, run by Addpharma Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCtau,ss(Area under the plasma drug concentration-time curve) (time frame: From Day 1 up to Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.