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PK Study for Multiple-dose

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021-50800743

Multiple oral PK studies in rodents (7 or 14 days)

GLP

No

Test product

TBD

The solvent

TBD

Systematic

Species

SD rat, CD-1 mouse and beagle dog

Week age

according to test requirements

Weight

according to test requirements

Quantity

3 males/group, half male and half female, total 18 (according to test requirements)

Test dose

group

Dose

sex/quantity

Po-low dose group

TBD

male /3, female /3,

Po-middle dose group

TBD

male /3, female /3,

Po-high dose group

TBD

male /3, female /3,

The frequency of administration

More than once

Dosage volume

Pre-dose weighing for dosing volume calculation (daily weight recording)

Clinical observation

The symptoms, weight/day, food intake/day were observed at each blood collection time point

Blood sample collection time

Day1: A total of 9 blood collection points in each group within 24 hours contained 0 points (pre-dose), EDTA-K2 anticoagulation

Day7: A total of 9 blood collection points in each group within 24 hours contained 0 points (pre-dose), EDTA-K2 anticoagulation

Day14: A total of 9 blood collection points in each group within 24 hours contained 0 points (pre-dose), EDTA-K2 anticoagulation

(Can be adjusted according to different requirements)

Analytical method

LC-MS/MS

Data presentation

 LC-MS/MSdetection of plasma concentration of the test substance (ng/mL) 

Tmax (h)

 t1/2 (h)

 F (%)

 AUC

 MRT

Concentration of 1 metabolite in each sample (if any)


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