Pharmacokinetic
Conditions
Brief summary
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.
Interventions
DRUGTQ-A3326
TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）
DRUGplacebo
Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female, age 18 to 60 years, inclusive. * The body weight of male is not less than 50kg, and female is not less than 45kg. All participants' body mass index (BMI) is between 19\ 26. * Adequate blood cell counts, kidney function and liver function. * Healthy participants should participate in the study voluntarily and sign informed consent.
Exclusion criteria
* Subjects with known allergy to the similar products tested. * Subject is on a special diet (for example subject is vegetarian). * Medical demographics with evidence of clinically significant deviation from normal medical condition. * Female subjects who were pregnant or nursing. * Results of laboratory tests which are clinically significant. * Acute infection within one week preceding first study drug administration. * History of drug or alcohol abuse. * Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study. * Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period. * ale subjects (or their partner) or female subjects have the unprotective sex behavior or have a planned pregnancy during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs). | Day 1 up to Day 7 for non-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. |
| Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements. | Day 1 up to Day 7 or Discharge. | 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. |
| Number of Participants With Marked Abnormalities in Laboratory Findings. | Day 1 up to Day 7. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax). | 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. | 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. |
| Maximum Observed Plasma Concentration (Cmax). | 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 | 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 |
| Apparent Total Body Clearance (CLT/F) | 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) 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. |
| Plasma Half-life (T-half) | 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 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. |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]). | 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 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. |
| Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time. | 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 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. |
Countries
China
Contacts
Primary ContactLi Xin, Doctor
Outcome results
None listed