Status:
UNKNOWN
Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects
Lead Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single oral dose of \[14C\]-20 mg/100 μCi Anaprazole Sodium enteric-coated capsule in healthy ...
Eligibility Criteria
Inclusion
- The subject is a Chinese adult male, 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 26.0 kg/m\^2, inclusive.
- 3\. Participants with evaluations of vital signs, physicial examination results,clinical laboratory and ECG testing outside the reference range that are deemed not clinically significant at investigator discretion at screening.
- The subject with childbearing potential agrees that the subject and his sexual partner use adequate contraception from signing of informed consent throughout the duration of the study and for 6 months after study completion.
- The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily
Exclusion
- Has clinical significant drug allergy or allergic disease history(Such as asthma, urticaria, eczema dermatitis, etc), or has hypersensitivity or allergy to investigatory drugs or related supplements；
- Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings)
- Any disease or medical history that may significantly affect the absorption, distribution, metabolism, and excretion of drugs, or any condition that may pose a hazard to the subject. Such as:
- Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal / rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities;
- Has suffered from gastrointestinal diseases or complications that may affect the absorption of drugs (ie: malabsorption, gastroesophageal reflux, peptic ulcer, erosive esophagitis, frequent heartburn) within 6 months before screening or had history of gastrointestinal surgery (for example: gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass, gastric segmentation or gastric banding, cholecystectomy, except for appendicitis surgery and proctectomy);
- Evidence of liver disease or clinically impaired liver function at the time of screening (eg AST, ALT or total bilirubin\> 1.5 times ULN);
- A history or evidence of nephropathy or renal insufficiency at the time of screening, showing clinically significant abnormality of creatinine or abnormal urine composition (such as proteinuria, creatinine\> 176.8 umol / L, etc.)
- Has difficulty swallowing oral preparations.
- Thyroid stimulating hormone (TSH)\> ULN; or serum free triiodothyronine (FT3)\> ULN; or serum free thyroxine (FT4)\> ULN at the time of screening;
- 5\. Frequent smokers and alcoholics within 3 months before screening (smoke more than 5 cigarettes / day, drink more than 21 units of alcohol per week, 1 unit = 360 mL beer or 45 mL liquor or 150 mL wine), or can't stop using any tobacco products, and alcohol intake during the study period ; or those who have a positive alcohol breath test before enrollment;
- 6\. Has received any investigational compound (including post-marketing investigational drugs) or participated in clinical trials of any drugs /devices within 3 months before screening;
- 7\. A history of drug abuse within 12 months before screening or a positive urine test result at screening;
- 8\. Has used any prescription drugs, non-prescription drugs (including chemical drugs, vitamin drugs, Chinese herbal medicines, etc.) within 4 weeks before administration of investigational drugs;
- 9\. Has taken foods that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 2 weeks before administration of investigational drugs;
- 10\. Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;
- 11\. Has difficulty in venous blood collection or halo acupuncture;
- Blood donation / blood loss ≥200 mL within 1 month, or ≥400 mL within 3 months before screening; or has blood donation plan during the period of medication of investigational drugs and within 3 months after drug withdrawal;
- 13\. Has special dietary requirements and cannot follow the unified dietary arrangements;
- 14\. Has particpated in another clinical study with radioactive labeling within 1 year before administration.
- 15\. Has significant radiation exposure (Radiation exposure from chest X-ray, CT scan or barium meal examination more than once, or be engaged in radiation related occupations) within 1 year before administration.
- 16\. Any conditions in which considered by investigator not be appropriate to participate in this trial.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04476394
Start Date
August 3 2020
End Date
September 30 2020
Last Update
July 20 2020
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