The General Hospital of the People's Liberation Army
Beijing, China
NCT Number: NCT03988413
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.
The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.
Looking for future studies?
Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SYHA1402 25mg or Placebo 25mg
SYHA1402 50mg or Placebo 50mg
SYHA1402 100mg or Placebo 100mg
SYHA1402 200mg or Placebo 200mg
SYHA1402 400mg or Placebo 400mg
SYHA1402 800mg or Placebo 800mg
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of blood pressure after administration of SYHA1402
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of heart rate after administration of SYHA1402
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess pulse after administration of SYHA1402
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of body temperature after administration of SYHA1402
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours
To assess the change of 12-lead ECG (PR,QRS,QT,QTc) after administration of SYHA1402
Time frame: 24, 48, 72 hours
To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402
Time frame: 24, 48, 72 hours
To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402
Time frame: 24, 48, 72 hours
To assess the change of blood routine after administration of SYHA1402
Time frame: 24, 48, 72 hours
To assess the change of urinary routine after administration of SYHA1402
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Plasma peak concentration (Cmax) after administration of SYHA1402
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Plasma peak time (Tmax) after administration of SYHA1402
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
The area under the plasma concentration-time curve of SYHA1402 after administration are calculated.
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
The half time of SYHA1402 after administration are calculated.
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
To assess the apparent clearance (CL/F) after administration of SYHA1402
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Industry
Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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