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PK Study for Single-dose Fecal and Urinary Excretion

PK Study for Single-dose Fecal and Urinary Excretion

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021-50800743

Study of PK in feces and urine excretion in rodents and/or non-rodents after single dosing

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/group, male and female half, a total of 6 (according to test requirements)

Test dose

group

Dose

sex/quantity

Group 1

TBD

male/3, female/3,

Route of administration

TBD

The frequency of administration

Single

Dosage volume

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

Clinical observation

Symptoms, body weight/day and food intake/day were observed at each collection time point

Blood sample collection time point

Within 24 hours after administration, 4 time periods are collected (can be adjusted according to different requirements)

Analytical method

LC-MS/MS

Data presentation

Drug recovery in feces and urine

Concentration of 1 metabolite in the sample at each time (if any)


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