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Trial record 6 of 215 for:    TETRACYCLINE

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

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ClinicalTrials.gov Identifier: NCT04066257
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

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
Healthy Drug: Tegoprazan Drug: Metronidazole Drug: Tetracycline Drug: Bismuth Phase 1

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

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Study Type : Interventional  (Clinical Trial)
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 : January 17, 2019
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: K-CAB

Drug: Metronidazole
Metronidazole 250 mg tablet
Other Name: Flasinyl

Drug: Tetracycline
Tetracycline hydrochloride 250 mg capsule
Other Name: Teracyclin

Drug: Bismuth
Tripotassium bismuth dicitrate 300 mg tablet
Other Name: 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 Name: Flasinyl

Drug: Tetracycline
Tetracycline hydrochloride 250 mg capsule
Other Name: Teracyclin

Drug: Bismuth
Tripotassium bismuth dicitrate 300 mg tablet
Other Name: Denol




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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

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.
  • H. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066257


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: Min-Gul Kim, MD Chonbuk university hospital

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT04066257     History of Changes
Other Study ID Numbers: CJ_APA_111
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CJ HealthCare Corporation:
Drug-Drug interaction
pharmacokinetic
Additional relevant MeSH terms:
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Tetracycline
Metronidazole
Bismuth
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors