Gastro Esophageal RefluxPhase 1NCT06025773
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121
A Phase 1 study testing Lansoprazole 15 mg and Lansoprazole 15mg/Calcium carbonate 600mg in people with Gastro Esophageal Reflux, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- Lansoprazole 15 mg and Lansoprazole 15mg/Calcium carbonate 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2023to 19 Apr 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with trouble performing Gastric pH monitoring
Trial locations and contacts
1 site in 1 country.
About this study
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
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.
Read the 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.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- Lansoprazole 15 mg, Lansoprazole 15mg/Calcium carbonate 600mg
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole 15 mgDrug
AD-2121 (Lansoprazole 15 mg), Oral, Capsule
Lansoprazole 15mg/Calcium carbonate 600mgDrug
AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | Experimental | Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A) Receives: Drug: Lansoprazole 15 mg; Drug: Lansoprazole 15mg/Calcium carbonate 600mg |
| Arm-B | Experimental | Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121) Receives: Drug: Lansoprazole 15 mg; Drug: Lansoprazole 15mg/Calcium carbonate 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
AUCτ,ss after 7days repeated administration of Lansoprazole
Measured: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
Percent Decrease from baseline of Integrated gastric acidity
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
Measured: 24 hours before 1st administration to 24 hours after repeated administration (7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start15 Sep 2023
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025773
- Sponsor's protocol ID
- AD-212PK/PD-03
- Status last verified
- Jul 2024
- First submitted
- 29 Aug 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06025773
- Acronym / sponsor ID
- AD-212PK/PD-03
- Conditions
- Gastro Esophageal Reflux
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 6 Sep 2023 (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.
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-A | Experimental | Drug: Lansoprazole 15 mg, Drug: Lansoprazole 15mg/Calcium carbonate 600mgPeriod 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A) |
| Arm-B | Experimental | Drug: Lansoprazole 15 mg, Drug: Lansoprazole 15mg/Calcium carbonate 600mgPeriod 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with trouble performing Gastric pH monitoring
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 |
|---|---|---|
| Lansoprazole 15 mgAD-2121 (Lansoprazole 15 mg), Oral, Capsule | Drug | Arm-A, Arm-B |
| Lansoprazole 15mg/Calcium carbonate 600mgAD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet | Drug | Arm-A, Arm-B |
Primary outcome
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
Time frame: 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
Time frame: 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
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 1 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lansoprazole 15 mg and Lansoprazole 15mg/Calcium carbonate 600mg in people with Gastro Esophageal Reflux, 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 1 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 1 Aug 2024. 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?
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss) (time frame: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)). 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 1 Aug 2024.