HealthyPhase 1NCT04066257
Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
A Phase 1 study testing Tegoprazan, Metronidazole and Tetracycline in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tegoprazan, Metronidazole and Tetracycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2019to 25 Apr 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged ≥ 19 and < 55 year-old on the day of obtaining the informed consent.
- Body mass index (BMI) ≥ 17.5 kg/m2 and < 28.0 kg/m2 with a body weight ≥ 55 kg at screening.
- H. pylori negative.
Who cannot join
- Medical History
- History or evidence of clinically significant disease
- History of gastrointestinal disease (e.g., esophageal disease such as esophageal achalasia or stenosis, and Crohn's disease) or surgery that may affect the absorption of a drug.
- History or presence of hypersensitivity to IMPs, components of IMPs, benzimidazoles, imidazole derivatives or tetracycline antibiotics
- Laboratory tests(in blood)
- 1) Total bilirubin, AST (GOT), ALT (GPT) > 1.5 X upper limit of normal (ULN) at screening
Show all 10Show fewer
- History of drug/alcohol abuse
- Participated in other study and received investigational product within 3 months prior to the first study dose.
- taken a medication known to substantially induce or inhibit a drug metabolizing enzyme
- Not able to use a medically acceptable contraceptive method throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction After Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.
Read the detailed description
A open-label, randomized, multiple dose, two arm, two period, crossover study
- Conditions
- Healthy
- Being tested
- Tegoprazan, Metronidazole, Tetracycline, Bismuth
- Keywords
- Drug-Drug interaction, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Also called K-CAB
Tegoprazan 50 mg tablet
MetronidazoleDrug
Also called Flasinyl
Metronidazole 250 mg tablet
TetracyclineDrug
Also called Teracyclin
Tetracycline hydrochloride 250 mg capsule
BismuthDrug
Also called Denol
Tripotassium bismuth dicitrate 300 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50 mg | Active comparator | Oral administration of Tegoprazan 50 mg twice daily for 7 days Receives: Drug: Tegoprazan |
| Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg | Active comparator | Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days Receives: Drug: Tegoprazan; Drug: Metronidazole; Drug: Tetracycline; Drug: Bismuth |
| MTN 500 mg+TCL 500 mg+BIS 300 mg | Active comparator | Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days Receives: Drug: Metronidazole; Drug: Tetracycline; Drug: Bismuth |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-12 of tegaprazan and metabolite M1
Area under the plasma concentration versus time curve of tegoprazan
Measured: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Cmax of tegaprazan and metabolite M1
Peak Plasma Concentration of tegoprazan and metabolite M1
Measured: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
AUC0-6 of metronidazole, tetracycline and bismuth
Area under the plasma concentration versus time curve of metronidazole, tetracycline and bismuth
Measured: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Cmax of metronidazole, tetracycline and bismuth
Peak Plasma Concentration of metronidazole, tetracycline and bismuth
Measured: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start17 Jan 2019
- Primary completion22 Feb 2019
- Study completion25 Apr 2019
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 HealthyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, MD, Principal investigator, Chonbuk university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066257
- Sponsor's protocol ID
- CJ_APA_111
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeon JY, Kim SY, Moon SJ, Oh K, Lee J, Kim B, Song GS, Kim MG. Pharmacokinetic Interactions between Tegoprazan and Metronidazole/Tetracycline/Bismuth and Safety Assessment in Healthy Korean Male Subjects. Clin Ther. 2021 Apr;43(4):722-734. doi: 10.1016/j.clinthera.2021.01.026. Epub 2021 Feb 23.
PubMed 33637332
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction After Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04066257
- Acronym / sponsor ID
- CJ_APA_111
- Conditions
- Healthy
- Keywords
- Drug-Drug interaction, pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 26 Aug 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.
This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.
Detailed description
A open-label, randomized, multiple dose, two arm, two period, crossover study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan 50 mg | Active comparator | Drug: TegoprazanOral administration of Tegoprazan 50 mg twice daily for 7 days |
| Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg | Active comparator | Drug: Tegoprazan, Drug: Metronidazole, Drug: Tetracycline, Drug: BismuthOral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days |
| MTN 500 mg+TCL 500 mg+BIS 300 mg | Active comparator | Drug: Metronidazole, Drug: Tetracycline, Drug: BismuthOral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult aged ≥ 19 and < 55 year-old on the day of obtaining the informed consent.
- Body mass index (BMI) ≥ 17.5 kg/m2 and < 28.0 kg/m2 with a body weight ≥ 55 kg at screening.
- H. pylori negative.
Key exclusion criteria (10 listed)
- Medical History
- Laboratory tests(in blood)
- 1) Total bilirubin, AST (GOT), ALT (GPT) > 1.5 X upper limit of normal (ULN) at screening
- History of drug/alcohol abuse
- Participated in other study and received investigational product within 3 months prior to the first study dose.
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 |
|---|---|---|
| TegoprazanAlso: K-CABTegoprazan 50 mg tablet | Drug | Tegoprazan 50 mg, Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg |
| MetronidazoleAlso: FlasinylMetronidazole 250 mg tablet | Drug | MTN 500 mg+TCL 500 mg+BIS 300 mg, Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg |
| TetracyclineAlso: TeracyclinTetracycline hydrochloride 250 mg capsule | Drug | MTN 500 mg+TCL 500 mg+BIS 300 mg, Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg |
| BismuthAlso: DenolTripotassium bismuth dicitrate 300 mg tablet | Drug | MTN 500 mg+TCL 500 mg+BIS 300 mg, Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg |
Primary outcome
AUC0-12 of tegaprazan and metabolite M1
Time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Area under the plasma concentration versus time curve of tegoprazan
Cmax of tegaprazan and metabolite M1
Time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Peak Plasma Concentration of tegoprazan and metabolite M1
AUC0-6 of metronidazole, tetracycline and bismuth
Time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Area under the plasma concentration versus time curve of metronidazole, tetracycline and bismuth
Cmax of metronidazole, tetracycline and bismuth
Time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Peak Plasma Concentration of metronidazole, tetracycline and bismuth
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 28 Aug 2019.
- Derived from this study: PubMed 33637332Jeon JY, Kim SY, Moon SJ, Oh K, Lee J, Kim B, Song GS, Kim MG. Pharmacokinetic Interactions between Tegoprazan and Metronidazole/Tetracycline/Bismuth and Safety Assessment in Healthy Korean Male Subjects. Clin Ther. 2021 Apr;43(4):722-734. doi: 10.1016/j.clinthera.2021.01.026. Epub 2021 Feb 23.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Min-Gul Kim, MD principal investigator
Chonbuk 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 Tegoprazan, Metronidazole and Tetracycline in people with Healthy, run by HK inno.N Corporation 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 10 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 28 Aug 2019. 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?
AUC0-12 of tegaprazan and metabolite M1 (time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.). The study lists 4 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 NCT04066257, 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 28 Aug 2019.