A Single-center, Randomized, Double-blinded, Placebo Parallel Controlled Phase 1 Study to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of Multiple Ascending Dose Administration of Anaprazole in Healthy Chinese Subjects

Sihuan Pharmaceutical Holdings Group Ltd.0 sites36 target enrollmentSeptember 8, 2015

ConditionsHealthy Volunteers

InterventionsAnaprazole Sodium enteric-coated tablet Placebo

DrugsAnaprazole Sodium enteric-coated tablet Placebo

Overview

Phase: Phase 1
Intervention: Anaprazole Sodium enteric-coated tablet
Conditions: Healthy Volunteers
Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Enrollment: 36
Primary Endpoint: Number of subjects with adverse events and serious adverse events as assessed by CTCAE v5.0
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (6 days) ascending dose (20mg QD, 40mg QD, 20mg Bid) administrationof Anaprazole in healthy Chinese subjects. 36 subjects, 12 subjects for each dose group. In each dose group, 10 subjects take anaprazole, 2 subjects take placebo.

Registry

clinicaltrials.gov

Start Date

September 8, 2015

End Date

December 29, 2015

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily;
•The subject is a Chinese health adult, aged 18 to 45 years, inclusive;
•The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg/m\^2 and 24.0 kg/m\^2, inclusive;
•Has clinical laboratory evaluations, vital signs and ECG testing within the reference range, and medical history and physicial examination results are normal. Participants with evaluations outside the reference range that are deemed not clinically significant by the investigator may be included at investigator discretion;
•No medical history of allergy to proton pump inhibitors and no any other drug allergy history;
•The subjects have a good lifestyle and can keep good communication with the investigators and comply with the requirements of clinical trial.

Exclusion Criteria

•Has postural hypotension, gastrointestinal disease (gastric ulcer, gastritis and etc), liver disease, renal disease (nephritis, pyelonephritis and etc), and other disease or medical history of any other system (cardiovascular, respiratory, psychoneural, hematology, endocrinology and etc) ;
•Has clinical significant abnormal electrolytes (especially hypopotassemia) in screening examination;
•Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings);
•Has rhinitis, allergic rhinitis, recurrent hemorrhinia, nasal deformity and abnormal nasal septum；
•With positive result of drug screening test;
•With positive result of nicotine test;
•Female participants who are pregnant, breast-feeding or menstral period, or participants has no effective contraception method, or has pregnancy plan in 6 months;
•Has received any drugs: acid-inhibitors, any priscription drug, herb medicine, non-prescription drugs and/or food suppliments (including vitamine) within 2 weeks before randomization;
•Blood donation / blood loss ≥400 mL within 3 months, or participated any other clinical trials within 3 months;
•Known Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;

Arms & Interventions

Anaprazole Sodium enteric-coated tablet

"Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.

Intervention: Anaprazole Sodium enteric-coated tablet

Placebo

Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.

Intervention: Placebo

Outcomes

Primary Outcomes

Number of subjects with adverse events and serious adverse events as assessed by CTCAE v5.0

Time Frame: From signing informed consent to study completion, 15 days after fist dose administration

All adverse events will be monitored in each subject

Secondary Outcomes

Cmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites(10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6)
Tmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites(10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6)
Time percentage of gastric pH value>4 in 24 hours gastric pH monitoring post dose at day 6(24 hours post-dose at day 6)
AUC of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites(10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6)
Time percentage of gastric pH value>3 in 24 hours gastric pH monitoring post dose at day 6(24 hours post-dose at day 6)