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Clinical Trial Details

Trial ID: L4220
Source ID: NCT04324424
Associated Drug: Hms5552
Title: A Clinical Study to Access the Pharmacokinetics of HMS5552 in Renal Impaired Subjects and Healthy Volunteers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: HMS5552
Outcome Measures: Primary: The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax, Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast, Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf, Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose., Up to 72 hours post-dose | Secondary: The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax,u (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast,u (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf,u (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Tmax (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of T1/2 (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of CL/F (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Vz/F (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of fu (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Ae (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose|The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of CLr (if applicable), Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., Up to 72 hours post-dose
Sponsor/Collaborators: Sponsor: Hua Medicine Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 17
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-04-23
Completion Date: 2019-09-30
Results First Posted:
Last Update Posted: 2020-03-27
Locations: West China Hospital of Sichuan University, Chengdu, Sichuan, 610000, China
URL: https://clinicaltrials.gov/show/NCT04324424