A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Parecoxib After Intravenous Bolus of Parecoxib in Healthy Volunteers Under Fasting Conditions
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax)
研究概览
简要总结
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of parecoxib after intravenous bolus of parecoxib in healthy volunteers under fasting conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
- •Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.
- •Acceptable medical history and physical examination including:
- •no particular clinically significant abnormalities in Electrocardiogram (ECG) results within six months prior to Period I dosing.
- •no particular clinical significance in general disease history within two months prior to Period I dosing.
- •Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes Alanine aminoTransferase (ALT), Aspartate aminoTransferase (AST), gamma-GT, alkaline phosphatase, total bilirubin, albumin, glucose, Blood urea nitrogen (BUN), uric acid, creatinine, total cholesterol, and triglyceride (TG).
- •Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials, and platelets.
- •Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin, and protein.
- •Subjects must use an acceptable method of birth control (e.g. abstinence, condom, intrauterine device, and vasectomy) for the duration of the study.
- •Have signed the written informed consent to participate in the study.
排除标准
- •A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
- •A clinically significant illness or surgery within four weeks prior to Period I dosing.
- •History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
- •History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
- •Known or suspected history of drug abuse within lifetime.
- •History of alcohol addiction or abuse within last five years.
- •History of allergic response(s) to parecoxib, valdecoxib or any other related drugs.
- •Evidence of chronic or acute infectious diseases.
- •Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
- •Female subjects demonstrating a positive pregnancy screen.
- •Female subjects who are currently breastfeeding.
- •Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to Period I dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone, and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone, and ranitidine.
- •Taking any prescription medications within four weeks or any nonprescription medications (excluding flu and COVID-19 vaccination) within two weeks prior to Period I dosing.
- •Use of any investigational drug (excluding COVID-19 vaccination) within four weeks prior to Period I dosing.
- •Use of any COVID-19 vaccine within seven days prior to Period I dosing.
- •Donating more than 250 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing.
- •Any other medical reason as determined by the investigator.
研究组 & 干预措施
Reference Drug
Active Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus)
干预措施: Parecoxib (Drug)
Test Drug
Active Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus)
干预措施: Parecoxib (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax)
时间窗: 0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)
Area under the concentration-time curve from time zero to time of last quantifiable
时间窗: 0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)
Area under the concentration-time curve from time zero to infinity (AUC 0-∞)
时间窗: 0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)
次要结局
未报告次要终点