Bioequivalence of Fluzoparib(SHR3162) Study on Healthy Chinese Adult Subjects

NCT04521192 | Completed Phase 1

• 1 other identifier: FZPL-I-BE-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the bioequivalence of two different specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100 mg/capsule, 1 capsule each) and test preparations capsules (50 mg/capsule×3). Two different specifications of fluzoparib was provided by Jiangsu HengRui Pharmaceutical Co., Ltd. The secondary objective of the study is to evaluate the safety of test preparations and reference preparation fluzoparib capsules of different specifications in healthy subjects.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of Fluzoparib

  Up to Day 10

• Area Under the Plasma Concentration(AUC) of Fluzoparib

  Up to Day 10

Secondary Outcomes (1)

• Adverse events

  Up to Day 28

Study Arms (2)

TR sequence group

EXPERIMENTAL

Drug: Fluzoparib

RT sequence group

EXPERIMENTAL

Drug: Fluzoparib

Interventions

Fluzoparib DRUG

the first period: test preparation; the second period: reference preparation

TR sequence group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form before the study, and fully understand the study content, process and possible adverse reactions;
• Able to complete the research in accordance with the requirements of the study protocol;
• Healthy male or female subjects aged 18-50 (including 18 or 50 years old) at the date of signing the informed consent;
• The subject is willing to have no pregnancy plan in the next 6 months and voluntarily take effective contraceptive measures
• Body weight ≥ 45kg, body mass index (BMI) within the range of 18 \~ 28kg /m2 (including 18 and 28);
• Health status: no history of heart, liver, kidney, digestive tract, nervous system, mental disorders, and metabolic disorders;
• No abnormalities in physical examination or abnormalities without clinical significance;
• Creatinine clearance rate (CLCr) ≥70 mL/min;
• Negative pregnancy test for women of child-bearing age;

You may not qualify if:

• Pregnant and lactating women, women who have unprotected sex in the 14 days before screening;
• Participated in blood donation within 3 months before screening and donated blood volume ≥400mL or blood loss ≥400mL, or received blood transfusion;
• Allergies, including those with a history of severe drug allergy or drug allergy; a history of allergy to fluzoparib capsules or its excipients.
• Have a history of drug and/or alcohol abuse; alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine; smoking ≥ 5 cigarettes per day) or Those who cannot ban smoking and alcohol during the trial;
• Those who have a history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia, and stroke;
• Lung diseases, including invasive lung disease, pneumonia, dyspnea, etc;
• History of chronic kidney disease, renal impairment, and renal anemia;
• There is a history of dysphagia or any gastrointestinal disease that affects drug absorption;
• Any uncontrolled peptic ulcer, colitis, pancreatitis, etc;
• Those who have undergone any surgery within 6 months before screening;
• A clear medical history of other important organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system (such as uncontrolled diabetes, high blood pressure, etc.), so that the investigator Those who think it is not suitable to participate in this research;
• Hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampin) taken within 6 months before screening;
• Those who have taken any clinical trial drugs within 3 months;
• Any drug that changes liver enzyme activity was taken 28 days before or during the study period;
• Take any prescription or over-the-counter drugs 7 days before taking the study drug;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The affiliated hospital of QingDao university

Qingdao, Qingdao, China

Location

MeSH Terms

Interventions

fluzoparib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose of oral administration of fluzoparib capsules

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 20, 2020
• Study Start: May 6, 2019
• Primary Completion: July 26, 2019
• Study Completion: September 5, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

CN (1)