Antitumor Drug, Pharmacokinetics
Conditions
Brief summary
The goal of this clinical trial is to evaluate the pharmacokinetic (PK) characteristics of single oral doses of SPH3348 tablets in healthy subjects under fasting and fed conditions, as well as the impact of food on PK.
Interventions
DRUGSPH3348
Single oral administration of SPH3348 tablets（480mg） under fasting and fed conditions
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
West China Second University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* To be eligible for this trial, participants must meet all the following inclusion criteria: 1. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, and sign an informed consent form, being able to complete all trial processes as required by the protocol; 2. Be healthy adult males or females aged 18 to 45 years, inclusive of the boundary values; 3. Have a body mass index (BMI) of 18 to 26 kg/m\^2, inclusive of the boundary values, with a minimum weight of 50 kg for males and 45 kg for females; 4. Participants with potential for fertility must use at least one medically recognized contraceptive method during the study treatment period and for one year after the end of the study treatment (contraceptive methods and requirements are detailed in Appendix 1); females must undergo a pregnancy test during the screening period or at admission, with a result that must be negative; and must not be breastfeeding.
Exclusion criteria
* Participants who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Cmax occurs within 1.5 to 4 hours after dosing | Peak Concentration |
| Tmax | From administration to reaching maximum plasma concentration, typically around 3 hours | Time to Reach Maximum Concentration |
| AUC0-t | AUC0-t is measured from time 0 to 32 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | through study completion, an average of 17 days |
Countries
China
Outcome results
None listed