Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
NCT ID: NCT04066257
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2019-01-17
2019-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Tegoprazan 50 mg
Oral administration of Tegoprazan 50 mg twice daily for 7 days
Tegoprazan
Tegoprazan 50 mg tablet
Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg
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
Tegoprazan
Tegoprazan 50 mg tablet
Metronidazole
Metronidazole 250 mg tablet
Tetracycline
Tetracycline hydrochloride 250 mg capsule
Bismuth
Tripotassium bismuth dicitrate 300 mg tablet
MTN 500 mg+TCL 500 mg+BIS 300 mg
Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days
Metronidazole
Metronidazole 250 mg tablet
Tetracycline
Tetracycline hydrochloride 250 mg capsule
Bismuth
Tripotassium bismuth dicitrate 300 mg tablet
Interventions
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Tegoprazan
Tegoprazan 50 mg tablet
Metronidazole
Metronidazole 250 mg tablet
Tetracycline
Tetracycline hydrochloride 250 mg capsule
Bismuth
Tripotassium bismuth dicitrate 300 mg tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≥ 17.5 kg/m2 and \< 28.0 kg/m2 with a body weight ≥ 55 kg at screening.
* H. pylori negative.
Exclusion Criteria
1. History or evidence of clinically significant disease
2. 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.
3. 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
* 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.
19 Years
55 Years
ALL
Yes
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Min-Gul Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Chonbuk university hospital
Locations
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Chonbuk National University Hospital
Jeonju, , South Korea
Countries
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References
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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.
Other Identifiers
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CJ_APA_111
Identifier Type: -
Identifier Source: org_study_id
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