Healthy VolunteerPhase 1NCT04324905
Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
A Phase 1 study testing HIP1802 and HGP1705 in people with Healthy Volunteer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- HIP1802 and HGP1705
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2020to 30 Oct 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers in the age between 19 and 50 years old.
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
- After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
- Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
Who cannot join
- Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
- Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
- Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
- Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
- Heavy smoker (>10 cigarettes/day).
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 HIP1802 to HGP1705 in Healthy Volunteers
A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Read the detailed description
A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
- Conditions
- Healthy Volunteer
- Being tested
- HIP1802, HGP1705
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP1802Drug
Test drug
HGP1705Drug
Reference drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Drug: HIP1802; Drug: HGP1705 |
| Sequence 2 | Experimental | Not described Receives: Drug: HIP1802; Drug: HGP1705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Measured: 0-24hours
Reduced rate from baseline in 24h integrated gastric pH
Measured: 0-24hours
Secondary outcomes (14)
Cmax
Measured: 0-24hours
Tmax
Measured: 0-24hours
t1/2
Measured: 0-24hours
CL/F
Measured: 0-24hours
Vd/F
Measured: 0-24hours
AUCtau
Measured: 0-24hours
Cmin,ss
Measured: 0-24hours
Cmax,ss
Measured: 0-24hours
t1/2,ss
Measured: 0-24hours
CLss/F
Measured: 0-24hours
Vd,ss/F
Measured: 0-24hours
Reduced rate from baseline in 24h integrated gastric pH
Measured: 0-24hours
Duration time with integrated gastric pH>4 / 24hr
Measured: 0-24hours
Median 24 hr gastric pH
Measured: 0-24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start29 Apr 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324905
- Sponsor's protocol ID
- HM-ESOB-101
- Status last verified
- Oct 2023
- First submitted
- 28 Feb 2020
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim Y, Bae S, Jeon I, Kwon J, Hong SH, Kim NY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Pharmacodynamics of a Fixed-Dose Combination of Esomeprazole and Magnesium Hydroxide Compared to the Enteric-Coated Esomeprazole. Clin Ther. 2024 Nov;46(11):870-876. doi: 10.1016/j.clinthera.2024.08.006. Epub 2024 Sep 16.
PubMed 39289057
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. 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 HIP1802 to HGP1705 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04324905
- Acronym / sponsor ID
- HM-ESOB-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 27 Mar 2020 (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 Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Detailed description
A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HIP1802, Drug: HGP1705 |
| Sequence 2 | Experimental | Drug: HIP1802, Drug: HGP1705 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers in the age between 19 and 50 years old.
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
- After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
- Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
Key exclusion criteria (5 listed)
- Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
- Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
- Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
- Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
- Heavy smoker (>10 cigarettes/day).
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 |
|---|---|---|
| HIP1802Test drug | Drug | Sequence 1, Sequence 2 |
| HGP1705Reference drug | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUClast
Time frame: 0-24hours
Reduced rate from baseline in 24h integrated gastric pH
Time frame: 0-24hours
14 secondary outcomes
Cmax
Time frame: 0-24hours
Tmax
Time frame: 0-24hours
t1/2
Time frame: 0-24hours
CL/F
Time frame: 0-24hours
Vd/F
Time frame: 0-24hours
AUCtau
Time frame: 0-24hours
Cmin,ss
Time frame: 0-24hours
Cmax,ss
Time frame: 0-24hours
t1/2,ss
Time frame: 0-24hours
CLss/F
Time frame: 0-24hours
Vd,ss/F
Time frame: 0-24hours
Reduced rate from baseline in 24h integrated gastric pH
Time frame: 0-24hours
Duration time with integrated gastric pH>4 / 24hr
Time frame: 0-24hours
Median 24 hr gastric pH
Time frame: 0-24hours
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 25 Oct 2023.
- Derived from this study: PubMed 39289057Kim Y, Bae S, Jeon I, Kwon J, Hong SH, Kim NY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Pharmacodynamics of a Fixed-Dose Combination of Esomeprazole and Magnesium Hydroxide Compared to the Enteric-Coated Esomeprazole. Clin Ther. 2024 Nov;46(11):870-876. doi: 10.1016/j.clinthera.2024.08.006. Epub 2024 Sep 16.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 HIP1802 and HGP1705 in people with Healthy Volunteer, run by Hanmi Pharmaceutical Company Limited 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 4 inclusion and 5 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 25 Oct 2023. 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?
AUClast (time frame: 0-24hours). 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?
On the ClinicalTrials.gov record for NCT04324905, which also lists 1 linked publication.
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 25 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.