Status:
COMPLETED
Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.
Detailed Description
A open-label, randomized, multiple dose, two arm, two period, crossover study
Eligibility Criteria
Inclusion
- 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
- 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)
- 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.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04066257
Start Date
January 17 2019
End Date
April 25 2019
Last Update
August 28 2019
Active Locations (1)
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1
Chonbuk National University Hospital
Jeonju, South Korea