- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04467060
A Single Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
July 7, 2020 updated by: Sihuan Pharmaceutical Holdings Group Ltd.
A Single-center, Randomized, Double-blinded, Placebo Parallel Controlled Phase 1 Study to Evaluate the Safety and Pharmacology of Single Ascending Dose Administration of Anaprazole in Healthy Chinese Subjects
A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects.
14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 25.0 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;
- Frequent alcoholics (drink more than 2 units of alcohol per day, 1 unit = 330 mL beer or 25 mL liquor or 125 mL wine), or took food or drinks with alcoholics 72 hours before randomization;
- Has taken foods or drinks with xanthine(cafeine) or intensive excercise. Has taken foods or drinks that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 14 days before administration of investigational drugs;
- Smoke more than 5 pieces per week;
- Any conditions in which considered by investigator not be appropriate to participate in this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anaprazole Sodium enteric-coated tablet
Single ascendinng dose (2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg), fasting oral administration.
|
2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg,fasting oral administration.
|
PLACEBO_COMPARATOR: Placebo
single dose, fasting oral administration
|
single dose, fasting oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, 8 days post-dose
|
All adverse events will be monitored in each subject
|
From signing informed consent to study completion, 8 days post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 14, 2014
Primary Completion (ACTUAL)
June 25, 2015
Study Completion (ACTUAL)
June 25, 2015
Study Registration Dates
First Submitted
June 30, 2020
First Submitted That Met QC Criteria
July 7, 2020
First Posted (ACTUAL)
July 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
June 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 3571-CPK-1001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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