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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Bismuth; Drug: Tetracycline; Drug: Metronidazole; Drug: Tegoprazan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04066257

CJ_APA_111

Details and patient eligibility

About

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

Full description

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

Enrollment: 32 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Tegoprazan 50 mg

Active Comparator group

Description:

Oral administration of Tegoprazan 50 mg twice daily for 7 days

Treatment:

Drug: Tegoprazan

Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg

Active Comparator group

Description:

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

Treatment:

Drug: Tegoprazan

Drug: Metronidazole

Drug: Tetracycline

Drug: Bismuth

MTN 500 mg+TCL 500 mg+BIS 300 mg

Active Comparator group

Description:

Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days

Treatment:

Drug: Metronidazole

Drug: Tetracycline

Drug: Bismuth