A Single-Center, Single-Dose, Randomized, Open-Label, Parallel Study of Relative Bioavailability With Oral Administration of New and Old Formulations of SHR3680 Tablets in Healthy Male Subjects Under Fasting Conditions

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country48 target enrollmentJanuary 6, 2021

ConditionsHealthy Male Subjects

Interventionstest SHR3680 tablets reference SHR3680 tablets

Drugstest SHR3680 tablets reference SHR3680 tablets

Overview

Phase: Phase 1
Intervention: test SHR3680 tablets
Conditions: Healthy Male Subjects
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 48
Locations: 1
Primary Endpoint: Fr
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions.

Registry

clinicaltrials.gov

Start Date

January 6, 2021

End Date

May 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
•Ability to complete the study as required by the protocol;
•Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent, and less than 10-year between minimum age and maximum age of the whole subjects;
•Body weight ≥ 50 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
•Agreement to avoid sperm donation for 3 months days after the dose of SHR3680;
•Glomerular filtration rate (GFR) ≥ 90mL / min / 1.73m2 (see Appendix 1 of the clinical trial protocol for the calculation formula of GFR);

Exclusion Criteria

•Any history of epilepsy, including childhood febrile seizures, loss of consciousness, transient ischemic attacks or any conditions that may lead to seizures, such as cerebrovascular disease, brain injury, stroke or brain cancer, etc;
•Any subject who had any clinically significant acute diseases within one month before screening, including fever or fever as his clinical symptoms, virus, bacteria (including upper respiratory tract infection) or fungi (non-skin) infections;
•Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor);
•Allergic constitution;
•History of drug use, or drug abuse screening positive;
•Alcoholic or often drinkers;
•A smoker with 5 cigarettes per day for more than 90 days;
•Positive serology for hepatitis B surface antigen (HBsAg) and HCV (healthy participants), anti-treponema pallidum virus (TP), or antihuman immunodeficiency virus (HIV) Type 1 and Type 2 (all subjects);
•Use of any drugs or substances known to be inhibitors or inducers of CYP enzymes within 90 days from the first dose or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to SHR3680 administration and during the study.
•A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.

Arms & Interventions

Test group

Test formulation of SHR3680

Intervention: test SHR3680 tablets

Reference group

Reference formulation of SHR3680.

Intervention: reference SHR3680 tablets

Outcomes

Primary Outcomes

Time Frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

Fr=AUC (test formulation)/AUC (reference formulation)

Cmax

Time Frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

AUC0-∞

Time Frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

AUC0-t

Time Frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

Secondary Outcomes

T1/2(predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing)
Vd(predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing)
CL/F(predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing)
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)(From the screening to the scheduled last visit day (Day 49±1 after dosing))
Tmax(predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing)