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Completed

NCT Number: NCT04066257

Evaluate the PK of 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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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)
  • 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.

Treatment and study plan

Tegoprazan

Drug

Tegoprazan 50 mg tablet

Other names: K-CAB

Metronidazole

Drug

Metronidazole 250 mg tablet

Other names: Flasinyl

Tetracycline

Drug

Tetracycline hydrochloride 250 mg capsule

Other names: Teracyclin

Bismuth

Drug

Tripotassium bismuth dicitrate 300 mg tablet

Other names: Denol

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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