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To study the single dose and multi-doses pharmacokinetic characteristics and tolerance of TQ-A3326 in the human body;To study the transformation of TQ-A3326;To study the effect of the food on the pharmacokinetic characteristics of TQ-A3326.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-A3326 | Experimental | TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses) |
|
| placebo | Experimental | Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-A3326 | Drug | TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs). | SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. | Day 1 up to Day 7 for non-SAEs . |
| Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements. | Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the subject. Weight was measured at the discharge. The criteria for clinically significant change was as per the investigators discretion. | Day 1 up to Day 7 or Discharge. |
| Number of Participants With Marked Abnormalities in Laboratory Findings. | Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*pre-treatment value, Leukocytes (low) as <0.9*lower limit of normal, Aspartate Aminotransferase (high) as >1.25*upper limit of normal, Creatinine (high) as >1.33*pre-treatment value, Bicarbonate (high) as >1.2*upper limit of normal, Total Protein (high) as >1.1*upper limit of normal, Creatinine Kinase (high) as >1.5*upper limit of normal, Blood in Urine (high) as ≥ 2*upper limit of normal. Participants were fasted for at least 10 hours prior to the collection of blood specimens for clinical laboratory tests. | Day 1 up to Day 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax). | Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay. 2)Grade 4 hematology toxicity | Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Xin, Doctor | Contact | +86-731-85171383 | naloxone@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Changsha | Recruiting | Changsha | Hunan | 410015 | China |
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| ID | Term |
|---|---|
| C000712047 | TQ-A3326 |
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| placebo |
| Drug |
Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses) |
|
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]). | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. It was calculated as the sum of linear trapezoids using non-compartmental analysis. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay. | Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1. |
| Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time. | Area under the plasma concentration-time curve from time zero extrapolated to infinite time was estimated as sum of AUC(0-T) and the extrapolated area, computed by the quotient of the last observable concentration and λ, where λ was the slopes of the terminal phases of the plasma concentration-time profiles. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay. | Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1. |
| Time to Reach Maximum Plasma Concentration (Tmax). | Tmax was defined as the time required to reach maximum observed plasma concentration. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay. | Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1. |
| Plasma Half-life (T-half) | Plasma half-life was defined as the time required for one half of the total amount of administered drug eliminated from the body. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay. | Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1. |
| Apparent Total Body Clearance (CLT/F) | Apparent total body clearance (CLT/F) was calculated as Dose/AUC(INF), where CLT was the clearance of the drug and F was the absolute oral bioavailability. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay. | Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1. |