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Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04066257
Collaborator
(none)
32
Enrollment
1
Location
3
Arms
3.2
Actual Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

A open-label, randomized, multiple dose, two arm, two period, crossover study

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 17, 2019
Actual Primary Completion Date :
Feb 22, 2019
Actual Study Completion Date :
Apr 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tegoprazan 50 mg

Oral administration of Tegoprazan 50 mg twice daily for 7 days

Drug: Tegoprazan
Tegoprazan 50 mg tablet
Other Names:
  • K-CAB

    		•
    Active Comparator: 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

    Drug: Tegoprazan
    Tegoprazan 50 mg tablet
    Other Names:
  • K-CAB

    • Drug: Metronidazole
    Metronidazole 250 mg tablet
    Other Names:
  • Flasinyl

    • Drug: Tetracycline
    Tetracycline hydrochloride 250 mg capsule
    Other Names:
  • Teracyclin

    • Drug: Bismuth
    Tripotassium bismuth dicitrate 300 mg tablet
    Other Names:
  • Denol

    		•
    Active Comparator: 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

    Drug: Metronidazole
    Metronidazole 250 mg tablet
    Other Names:
  • Flasinyl

    • Drug: Tetracycline
    Tetracycline hydrochloride 250 mg capsule
    Other Names:
  • Teracyclin

    • Drug: Bismuth
    Tripotassium bismuth dicitrate 300 mg tablet
    Other Names:
  • Denol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC0-12 of tegaprazan and metabolite M1 [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

    2. Cmax of tegaprazan and metabolite M1 [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

    3. AUC0-6 of metronidazole, tetracycline and bismuth [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

    4. Cmax of metronidazole, tetracycline and bismuth [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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.

      1. pylori negative.
    Exclusion Criteria:
    • Medical History

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonbuk National University Hospital Jeonju Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

    • Principal Investigator: Min-Gul Kim, MD, Chonbuk university hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HK inno.N Corporation
    ClinicalTrials.gov Identifier:
    NCT04066257
    Other Study ID Numbers:
    • CJ_APA_111
    First Posted:
    Aug 26, 2019
    Last Update Posted:
    Aug 28, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by HK inno.N Corporation
    Drug-Drug interaction
    pharmacokinetic
    Additional relevant MeSH terms:
    Metronidazole
    Tetracycline
    Bismuth

    Study Results

    No Results Posted as of Aug 28, 2019