HealthyPhase 1NCT05915871
Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin
A Phase 1 study testing Tegoprazan, Bismuth and Amoxicilli in people with Healthy, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetic interaction between tegoprazan and combination of Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tegoprazan, Bismuth and Amoxicilli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 28 Apr 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Subjects fully understand the objectives, nature, method, possible AEs of the trial, voluntarily participate in this clinical study, sign the ICF in person prior to the start of any study procedure, and promise that they will participate in all the study procedures in person.
- 2. Chinese healthy male and non-lactating female subjects who are 18 to 55 years of age (inclusive) at the signing of ICF.
- 3. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive); and male weight ≥ 50.0 kg, female weight ≥ 45.0 kg.
- 4. Subjects can communicate well with the investigator and understand and comply with various requirements of the study.
Who cannot join
- 1. Diseases with prior and current abnormal clinical manifestations to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, and bones.
- 2. People with a history of specific allergy (asthma, urticaria, eczema, etc.), an allergic constitution, or known hypersensitivity to tegoprazan, bismuth potassium citrate, amoxicillin, clarithromycin, penicillin, and macrolide antibiotics, or hypersensitivity to any ingredient of the drug products.
- 3. Positive reaction to penicillin skin test. 4. History of active ulcer or significant hemorrhage from gastrointestinal tract, genitourinary tract or respiratory tract, or central nervous system hemorrhage.
- 5. History of dysphagia or any gastrointestinal disorder affecting drug absorption (as judged by the investigator).
- 6. Surgery within 3 months prior to screening, or planning to receive surgery during the study, and history of any surgery that may affect drug absorption (e.g., gastrectomy).
- 7. Intolerance to venipuncture, or history of fear of needles or blood. 8. Lactose intolerance (history of diarrhea due to drinking milk). 9. History of illicit drug abuse within 6 months prior to screening, history of illicit drug use, or urine drug screen test positive.
Show all 25Show fewer
- 10. Mean alcohol use > 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer, 150 mL of wine, or 45 mL of spirit) per week within 3 months prior to screening, or alcohol breath test positive, or inability to stop drinking during the trial period.
- 11. Mean daily smoking > 5 cigarettes within 3 months prior to screening, or inability to stop using any tobacco products during the trial period.
- 12. Participation in any clinical trial of other investigational drug/device within 3 months prior to the first dose of study drug, or participation in 3 or more drug/device clinical trials in the past one year; if the half-life of other study drugs is long (5 half-lives exceed 3 months), the time interval required will be longer, i.e., 5 half-lives of the drug.
- 13. Blood donation including donating blood components or massive blood loss (≥ 200 mL) within 3 months prior to screening; blood transfusion or use of blood products within 3 months prior to screening.
- 14. History of vaccination within 1 month prior to screening, or planned vaccination during the study period.
- 15. Use of any drugs inhibiting or inducing hepatic drug metabolism within 28 days prior to first dose of study drug.
- 16. Use of any prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicines within 14 days prior to first dose.
- 17. Any of the hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody, or anti-Treponema pallidum specific antibody tests is positive.
- 18. At the time of screening, the results of vital signs (blood pressure, pulse rate, and body temperature), physical examination, and laboratory tests (complete blood count, blood chemistry, coagulation, and urinalysis) are judged as abnormal and clinically significant by the investigator.
- 19. In the supine 12-lead ECG performed after at least 10 minutes of quiet rest during screening, QT interval corrected by Fridericia's formula (QTcF) > 470 msec (female)/450 msec (male) [Fridericia's formula is QTcF = QT/(RR)1/3] or QRS complex > 120 msec [if the QTcF of the 1st measurement exceeds 450 msec (female QTcF > 470 msec) or QRS > 120 msec, 12-lead ECG measurements should be repeated 2 times, and a judgment should be made using the mean QTcF or QRS value of the 3 measurements].
- 20. Subjects with a history of prolonged QT interval or ventricular arrhythmia (including torsade de pointes).
- 21. Subjects with hypokalemia (at risk of prolonged QT interval). 22. Creatinine clearance (CLCr) < 90 mL/min. The calculation method of creatinine clearance is shown in Appendix 4.
- 23. Subjects who cannot stop taking strenuous exercise within 48 hours prior to first dose of study drug and during the trial period.
- 24. Subjects who consume any alcohol-containing, caffeine-containing, or xanthine-rich food or beverage within 48 hours prior to first dose of study drug; or cannot stop consuming such products during the trial period.
- 25. Subjects who consume pitaya, mango, grapefruit, or grapefruit-related citrus fruits (e.g., pomegranate, starfruit, Seville orange, and pomelo) or food or beverage prepared from such fruits within 7 days prior to first dose of study drug, or cannot stop taking these fruits or food or beverage prepared from them during the trial period.
- 26. Subject or his/her partner has planned parenthood, or is unwilling to take effective contraceptive measures (see Appendix 1 for details), or has a sperm or egg donation plan throughout the study and within 3 months after last dose of study drug. Female subjects who do not take effective contraceptive measures within 15 days prior to screening.
- 27. Female subjects who have a positive blood pregnancy test at screening. 28. Unwillingness or inability to follow the lifestyle guidance (e.g., dietary restrictions and activity requirements) described in the study protocol.
- 29. Subjects have other acute or chronic medical or psychiatric disorders and thereby are judged by the investigator as not suitable for participating in this study, which may increase the risk related to this study or may interfere with the interpretation of study results.
- 30. Other subjects who are judged unsuitable for participation in the clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: An Open-label, Fixed-sequence Study to Evaluate the Drug-drug Interactions Between Tegoprazan Tablets and Bismuth Potassium Citrate Capsules, Amoxicillin Capsules, and Clarithromycin Tablets in Healthy Subjects
To evaluate the pharmacokinetic interaction between tegoprazan and combination of Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers.
Read the detailed description
To evaluate the pharmacokinetic interaction between tegoprazan and combination of Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers.
- Conditions
- Healthy
- Being tested
- Tegoprazan, Bismuth, Amoxicilli, Clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Tablet for oral administration
BismuthDrug
Capsule for oral administration
AmoxicilliDrug
Capsule for oral administration
ClarithromycinDrug
Tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan, Bismuth, Amoxicillin and Clarithromycin | Experimental | Oral administration of Tegoprazan 50 mg twice daily on Days 1 to 7. Oral administration of Bismuth 600 mg twice daily, Amoxicilli 1000 mg twice daily and Clarithromycin 500 mg twice daily on Days 14 to 20.
Oral administration of Tegoprazan 50 mg twice daily, Bismuth 600 mg twice daily, Amoxicilli 1000 mg twice daily and Clarithromycin 500mg twice daily on Days 21 to 27. Receives: Drug: Tegoprazan; Drug: Bismuth; Drug: Amoxicilli; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau of Tegoprazan, Bismuth, Amoxicillin, and Clarithromycin Following Multiple Oral Doses
Area under the curve over a 12-hour dosing interval at steady state (AUCtau)
Measured: Up to Day 27
Cmax,ss of Tegoprazan, Bismuth, Amoxicillin, and Clarithromycin Following Multiple Oral Doses
Steady state maximum concentration (Cmax,ss)
Measured: Up to Day 27
Secondary outcomes (13)
Tmax,ss of tegoprazan, bismuth, amoxicillin, and clarithromycin
steady-state time to reach maximum concentration (Tmax,ss)
Measured: Up to Day 27
T1/2 of tegoprazan, bismuth, amoxicillin, and clarithromycin
elimination half-life (t1/2)
Measured: Up to Day 27
CL/F of tegoprazan, bismuth, amoxicillin, and clarithromycin
apparent clearance (CL/F)
Measured: Up to Day 27
Vdss/F of tegoprazan, bismuth, amoxicillin, and clarithromycin
apparent volume of distribution (Vdss/F)
Measured: Up to Day 27
Cmax,ss of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin
Steady state maximum concentration (Cmax,ss)
Measured: Up to Day 27
AUCtau of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin
Area under the curve over a 12-hour dosing interval at steady state (AUCtau)
Measured: Up to Day 27
Tmax,ss of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin
steady-state time to reach maximum concentration (Tmax,ss)
Measured: Up to Day 27
T1/2 of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin
elimination half-life (t1/2)
Measured: Up to Day 27
Number of Participants With Adverse Events
Measured: Up to Day 34
Number of Participants With Clinically Notable Electrocardiogram (ECG) Values
Measured: Up to Day 28
Number of Participants With Clinically Notable Laboratory Tests
Measured: Up to Day 28
Number of Participants With Clinically Notable Vital Signs
Measured: Up to Day 28
Number of Participants With Clinically Notable Physical Exam
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start23 Mar 2023
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915871
- Sponsor's protocol ID
- NE822202
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 23 Jun 2023
- 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 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence Study to Evaluate the Drug-drug Interactions Between Tegoprazan Tablets and Bismuth Potassium Citrate Capsules, Amoxicillin Capsules, and Clarithromycin Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05915871
- Acronym / sponsor ID
- NE822202
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 23 Jun 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.
To evaluate the pharmacokinetic interaction between tegoprazan and combination of Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers.
Detailed description
To evaluate the pharmacokinetic interaction between tegoprazan and combination of Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan, Bismuth, Amoxicillin and Clarithromycin | Experimental | Drug: Tegoprazan, Drug: Bismuth, Drug: Amoxicilli, Drug: ClarithromycinOral administration of Tegoprazan 50 mg twice daily on Days 1 to 7. Oral administration of Bismuth 600 mg twice daily, Amoxicilli 1000 mg twice daily and Clarithromycin 500 mg twice daily on Days 14 to 20. Oral administration of Tegoprazan 50 mg twice daily, Bismuth 600 mg twice daily, Amoxicilli 1000 mg twice daily and Clarithromycin 500mg twice daily on Days 21 to 27. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Subjects fully understand the objectives, nature, method, possible AEs of the trial, voluntarily participate in this clinical study, sign the ICF in person prior to the start of any study procedure, and promise that they will participate in all the study procedures in person.
- 2. Chinese healthy male and non-lactating female subjects who are 18 to 55 years of age (inclusive) at the signing of ICF.
- 3. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive); and male weight ≥ 50.0 kg, female weight ≥ 45.0 kg.
- 4. Subjects can communicate well with the investigator and understand and comply with various requirements of the study.
Key exclusion criteria (25 listed)
- 1. Diseases with prior and current abnormal clinical manifestations to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, and bones.
- 2. People with a history of specific allergy (asthma, urticaria, eczema, etc.), an allergic constitution, or known hypersensitivity to tegoprazan, bismuth potassium citrate, amoxicillin, clarithromycin, penicillin, and macrolide antibiotics, or hypersensitivity to any ingredient of the drug products.
- 3. Positive reaction to penicillin skin test. 4. History of active ulcer or significant hemorrhage from gastrointestinal tract, genitourinary tract or respiratory tract, or central nervous system hemorrhage.
- 5. History of dysphagia or any gastrointestinal disorder affecting drug absorption (as judged by the investigator).
- 6. Surgery within 3 months prior to screening, or planning to receive surgery during the study, and history of any surgery that may affect drug absorption (e.g., gastrectomy).
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 |
|---|---|---|
| TegoprazanTablet for oral administration | Drug | Tegoprazan, Bismuth, Amoxicillin and Clarithromycin |
| BismuthCapsule for oral administration | Drug | Tegoprazan, Bismuth, Amoxicillin and Clarithromycin |
| AmoxicilliCapsule for oral administration | Drug | Tegoprazan, Bismuth, Amoxicillin and Clarithromycin |
| ClarithromycinTablet for oral administration | Drug | Tegoprazan, Bismuth, Amoxicillin and Clarithromycin |
Primary outcome
AUCtau of Tegoprazan, Bismuth, Amoxicillin, and Clarithromycin Following Multiple Oral Doses
Time frame: Up to Day 27
Area under the curve over a 12-hour dosing interval at steady state (AUCtau)
Cmax,ss of Tegoprazan, Bismuth, Amoxicillin, and Clarithromycin Following Multiple Oral Doses
Time frame: Up to Day 27
Steady state maximum concentration (Cmax,ss)
13 secondary outcomes
Tmax,ss of tegoprazan, bismuth, amoxicillin, and clarithromycin
Time frame: Up to Day 27
T1/2 of tegoprazan, bismuth, amoxicillin, and clarithromycin
Time frame: Up to Day 27
CL/F of tegoprazan, bismuth, amoxicillin, and clarithromycin
Time frame: Up to Day 27
Vdss/F of tegoprazan, bismuth, amoxicillin, and clarithromycin
Time frame: Up to Day 27
Cmax,ss of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin
Time frame: Up to Day 27
AUCtau of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin
Time frame: Up to Day 27
Tmax,ss of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin
Time frame: Up to Day 27
T1/2 of M1 (tegoprazan metabolite) and 14-hydroxyclarithromycin
Time frame: Up to Day 27
Number of Participants With Adverse Events
Time frame: Up to Day 34
Number of Participants With Clinically Notable Electrocardiogram (ECG) Values
Time frame: Up to Day 28
Number of Participants With Clinically Notable Laboratory Tests
Time frame: Up to Day 28
Number of Participants With Clinically Notable Vital Signs
Time frame: Up to Day 28
Number of Participants With Clinically Notable Physical Exam
Time frame: Up to Day 28
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 23 Jun 2023.
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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 Tegoprazan, Bismuth and Amoxicilli in people with Healthy, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.
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 25 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 23 Jun 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 China. 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 of Tegoprazan, Bismuth, Amoxicillin, and Clarithromycin Following Multiple Oral Doses (time frame: Up to Day 27). 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 23 Jun 2023.