A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsul… (NCT05427682) | Clinical Trial Compass
CompletedPhase 1
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage
China32 participantsStarted 2022-04-19
Plain-language summary
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in subjects with mild and moderate liver damage and healthy subjects
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sign the informed consent form before the experiment, understand and abide by the research process, and participate voluntarily;
* Adult subjects between the ages of 18 and 70 (including boundary values), both male and female;
* Female subjects or male subjects with potential fertility must agree to use effective contraceptive methods (see Appendix 2 for specific contraceptive methods) from signing informed consent to taking the trial drug within 4 weeks to avoid pregnancy or make their partners pregnant.
* The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): the gender and age (+ or - 5 years) of subjects in groups A and C are matched with subjects in groups B and D respectively;
* The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): body mass index (BMI): 18-30kg/m2 (including cut-off value) \[BMI=weight (kg)/height 2 (m2) )\] (BMI matching between groups A and C and groups B and D is + or - 15%);
* The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): medical history, physical examination, vital signs monitoring, electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation) Function), alpha-fetoprotein (AFP), abdominal B-ultrasound (liver, spleen, gallbladder, pancreas, kidneys), and chest radiographs have normal or abnorm…
What they're measuring
1
Cmax
Timeframe: 0 hour(pre-dose) to 96 hours after administration
2
AUC
Timeframe: 0 hour(pre-dose) to 96 hours after administration