Healthy Volunteer
Conditions
Brief summary
To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.
Detailed description
By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.
Interventions
DRUGSH-1028 Tablets
200mg of SH-1028 Tablets, orally once every cycle.
Sponsors
Nanjing Sanhome Pharmaceutical, Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Subject with acceptable laboratory results. 2. BMI between 19 and 26; Weight between 50 and 80 kg 3. Not allowed to smoke or drink during the trial. 4. Subject should be willing to contracept during the study and until 6 months after completion of study.
Exclusion criteria
1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator. 2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity 3. Addicted to smoking and drinking. 4. Hemorrhage over 200mL in 3 months before the trial. 5. Other conditions not suitable for trial, by judgement of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC) | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2(Each cycle is 4 days with a 3-days interval). |
| Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration [AUC(0-t)] | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval). |
| Pharmacokinetic of SH-1028 Tablets by assessment of time to Cmax (tmax) | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval). |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic of SH-1028 Tablets by assessment of terminal rate constant (λz) [ | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval). |
| Pharmacokinetic of SH-1028 Tablets by assessment of Terminal half life (t1/2） | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval). |
| Pharmacokinetic of SH-1028 Tablets by assessment of AUC[%Extrap obs],the rate of AUC(t-∞) to AUC | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval). |
| Pharmacokinetic of SH-1028 Tablets by assessment of apparent volume of distribution (Vz/F) | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval). |
| Pharmacokinetic of SH-1028 Tablets by assessment of Mean Residence Time（MRT） | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval). |
| Pharmacokinetic of SH-1028 Tablets by assessment of apparent plasma clearance (CL/F) | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval). |
| Adverse event（AE）rate and serious adverse event（SAE）rate | From signing of informed consent to ending of the trial, about 25 days. |
| Pharmacokinetic of SH-1028 Tablets by assessment of maximum plasma concentration (Cmax) | Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval). |
Contacts
Primary ContactZhou Huan, associate professor
Outcome results
None listed