| Eligibility |
Inclusion Criteria:
- 1. Subjects fully understand the objectives, nature, method, possible AEs of the
trial, voluntarily participate in this clinical study, sign the ICF in person prior to
the start of any study procedure, and promise that they will participate in all the
study procedures in person.
2. Chinese healthy male and non-lactating female subjects who are 18 to 55 years of
age (inclusive) at the signing of ICF.
3. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive); and male weight = 50.0 kg,
female weight = 45.0 kg.
4. Subjects can communicate well with the investigator and understand and comply with
various requirements of the study.
Exclusion Criteria:
- 1. Diseases with prior and current abnormal clinical manifestations to be excluded,
including but not limited to diseases of the nervous system, cardiovascular system,
blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract,
respiratory system, metabolism, and bones.
2. People with a history of specific allergy (asthma, urticaria, eczema, etc.), an
allergic constitution, or known hypersensitivity to tegoprazan, bismuth potassium
citrate, amoxicillin, clarithromycin, penicillin, and macrolide antibiotics, or
hypersensitivity to any ingredient of the drug products.
3. Positive reaction to penicillin skin test. 4. History of active ulcer or
significant hemorrhage from gastrointestinal tract, genitourinary tract or respiratory
tract, or central nervous system hemorrhage.
5. History of dysphagia or any gastrointestinal disorder affecting drug absorption (as
judged by the investigator).
6. Surgery within 3 months prior to screening, or planning to receive surgery during
the study, and history of any surgery that may affect drug absorption (e.g.,
gastrectomy).
7. Intolerance to venipuncture, or history of fear of needles or blood. 8. Lactose
intolerance (history of diarrhea due to drinking milk). 9. History of illicit drug
abuse within 6 months prior to screening, history of illicit drug use, or urine drug
screen test positive.
10. Mean alcohol use > 14 units of alcohol (1 unit of alcohol ˜ 360 mL of beer, 150 mL
of wine, or 45 mL of spirit) per week within 3 months prior to screening, or alcohol
breath test positive, or inability to stop drinking during the trial period.
11. Mean daily smoking > 5 cigarettes within 3 months prior to screening, or inability
to stop using any tobacco products during the trial period.
12. Participation in any clinical trial of other investigational drug/device within 3
months prior to the first dose of study drug, or participation in 3 or more
drug/device clinical trials in the past one year; if the half-life of other study
drugs is long (5 half-lives exceed 3 months), the time interval required will be
longer, i.e., 5 half-lives of the drug.
13. Blood donation including donating blood components or massive blood loss (= 200
mL) within 3 months prior to screening; blood transfusion or use of blood products
within 3 months prior to screening.
14. History of vaccination within 1 month prior to screening, or planned vaccination
during the study period.
15. Use of any drugs inhibiting or inducing hepatic drug metabolism within 28 days
prior to first dose of study drug.
16. Use of any prescription drugs, over-the-counter drugs, dietary supplements, or
Chinese herbal medicines within 14 days prior to first dose.
17. Any of the hepatitis B surface antigen, hepatitis C virus antibody, anti-human
immunodeficiency virus antibody, or anti-Treponema pallidum specific antibody tests is
positive.
18. At the time of screening, the results of vital signs (blood pressure, pulse rate,
and body temperature), physical examination, and laboratory tests (complete blood
count, blood chemistry, coagulation, and urinalysis) are judged as abnormal and
clinically significant by the investigator.
19. In the supine 12-lead ECG performed after at least 10 minutes of quiet rest during
screening, QT interval corrected by Fridericia's formula (QTcF) > 470 msec
(female)/450 msec (male) [Fridericia's formula is QTcF = QT/(RR)1/3] or QRS complex >
120 msec [if the QTcF of the 1st measurement exceeds 450 msec (female QTcF > 470 msec)
or QRS > 120 msec, 12-lead ECG measurements should be repeated 2 times, and a judgment
should be made using the mean QTcF or QRS value of the 3 measurements].
20. Subjects with a history of prolonged QT interval or ventricular arrhythmia
(including torsade de pointes).
21. Subjects with hypokalemia (at risk of prolonged QT interval). 22. Creatinine
clearance (CLCr) < 90 mL/min. The calculation method of creatinine clearance is shown
in Appendix 4.
23. Subjects who cannot stop taking strenuous exercise within 48 hours prior to first
dose of study drug and during the trial period.
24. Subjects who consume any alcohol-containing, caffeine-containing, or xanthine-rich
food or beverage within 48 hours prior to first dose of study drug; or cannot stop
consuming such products during the trial period.
25. Subjects who consume pitaya, mango, grapefruit, or grapefruit-related citrus
fruits (e.g., pomegranate, starfruit, Seville orange, and pomelo) or food or beverage
prepared from such fruits within 7 days prior to first dose of study drug, or cannot
stop taking these fruits or food or beverage prepared from them during the trial
period.
26. Subject or his/her partner has planned parenthood, or is unwilling to take
effective contraceptive measures (see Appendix 1 for details), or has a sperm or egg
donation plan throughout the study and within 3 months after last dose of study drug.
Female subjects who do not take effective contraceptive measures within 15 days prior
to screening.
27. Female subjects who have a positive blood pregnancy test at screening. 28.
Unwillingness or inability to follow the lifestyle guidance (e.g., dietary
restrictions and activity requirements) described in the study protocol.
29. Subjects have other acute or chronic medical or psychiatric disorders and thereby
are judged by the investigator as not suitable for participating in this study, which
may increase the risk related to this study or may interfere with the interpretation
of study results.
30. Other subjects who are judged unsuitable for participation in the clinical trial
by the investigator.
|
