gw117 odt （orally disintegrating tablets） safety and pharmacokinetics study in healthy subjects

Conditions: Major Depressive Disorder

Summary: to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of gw117 odt in healthy volunteers

single ascending dose (sad), multiple ascending dose (mad), double-blind placebo-controlled study in chinese healthy volunteers.

Eligibility criteria:
inclusion criteria: * body weight should be at least 50.0kg for males and 45.0kg for females, with body mass index (weight/height 2) in the range of 19-26 kg/m2 * the results of physical examination were normal or abnormal without clinical significance; * the results of vital signs were normal or abnormal without clinical significance * the results of laboratory tests (blood routine, urine routine, liver function, renal function, blood glucose, electrolytes, coagulation function) were normal or abnormal without clinical significance * negative results of pregnancy examination * normal serological test results (five hepatitis b tests, hepatitis c antibodies, syphilis sero-specific antibodies, hiv antibodies) * normal or approximately normal or abnormal results of 12-lead electrocardiogram were not clinically significant * normal or abnormal chest x-ray findings had no clinical significance * the normal or abnormal results of abdominal ultrasound had no clinical significance; * alcohol breath test results were negative * urine nicotine test results were negative * urine drug screening (morphine, methamphetamines, ketamine, dimethylenedioxyamphetamine, and tetrahydrocannabinol acid) was negative exclusion criteria: * allergic constitution or a history of drug or food allergy * any medical history that may affect the safety of the trial or the in vivo course of the drug * any history of surgery or trauma that may affect the safety of the trial or the course of the drug in vivo * currently suffering from any unstable or recurrent disease or disease affecting the course of the drug in vivo * a history of drug abuse/dependence in the past 2 years * any medications used within 14 days before the test * smoking within 2 weeks before medication or during the study period; * alcohol abuse \[drinking more than 14 units of alcohol per week in the 3 months before screening (1 unit of alcohol ≈360ml of 5% beer or 45ml of 40% spirits or 150ml of 12% wine)\], or drinking alcohol within 1 week before medication, or unable to abstain from alcohol during the study * participated in other drug clinical trials within 90 days before the trial * blood loss or donation of 400ml or more within 90 days before the test; * a history of fainting or bleeding * lactating women * plan to donate sperm or egg, plan to have children, or be unwilling or unable to take effective contraceptive measures within 30 days before the trial to 6 months after the end of the trial * abnormal neurological or mental status or language disorder * patients with abnormal saliva secretion, severe oral ulcer or other oral mucosal diseases; * the investigators considered that they were not suitable to participate in the trial due to other circumstances

Keywords: mdd gw117 depression