This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets. A total of 60 obese or overweight subjects are planned to be enrolled, with no less than one-quarter of the subjects from either gender. The study duration for each subject in this study is approximately 26 weeks: including a screening period of up to 4 weeks (W-28 to D-1), single-drug administration and dose escalation stages of 16 weeks (W1D1 to W16D7) and the combined drug administration stage of 6 weeks (W17D1 to W23D1)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
GZR18 injection: 3 mg-36 mg,16 weeks; Warfarin Sodium Tablets:2.5mg,twice; Rosuvastatin Calcium Tablets:10mg,twice; Digoxin Tablets:0.25mg,twice
Study site 01
Beijing, China
RECRUITINGCmax:Maximum plasma concentration
Time frame: through study completion,up to 16 weeks
AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
Time frame: through study completion,up to 16 weeks
AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
Time frame: through study completion,up to 16 weeks
Tmax:Time of Maximum Drug Concentration
Time frame: through study completion,up to 16 weeks
t1/2: Elimination half-life
Time frame: through study completion,up to 16 weeks
CL/F: Apparent clearance rate
Time frame: through study completion,up to 16 weeks
Vz/F:Apparent Volume of Distribution associated with the Terminal Phase following Oral Administration
Time frame: through study completion,up to 16 weeks
PD:Area under the international normalized ratio-time curve (INRAUC) and maximum international normalized ratio postdose (INRMAX) for warfarin
Time frame: through study completion,up to 16 weeks
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