A Single-Dose, Randomized, Open-Label, Two-Treatment, Four-Period, Crossover Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Subjects Compared With Clarityne Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for Loratadine
研究概览
简要总结
The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •If a woman, must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (for example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry, throughout the study, and for 1 month after the last dose of study drug
- •If a woman, must have a negative serum pregnancy test at screening and a negative serum pregnancy test on Day -1 of each treatment period
- •If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug
- •If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (for example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Must agree to continue using an appropriate method of birth control during the study and for 3 months after the last dose of study drug
- •Body mass index (BMI, weight [kilogram]/height^2 [meter^2] {[kg]/height2 [m]2}) between 19.0 and 26.0 kilogram per meter square (kg/m2) (inclusive); body weight of male participants not less than 50 kilogram (kg) and body weight of female participants not less than 45 kg
排除标准
- •History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), gastrointestinal disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
- •Clinically significant abnormal physical examination, or vital signs at screening or on Day -1 of each treatment period as deemed appropriate by the investigator
- •Use of any prescription or Over-the-counter (OTC) drug (including vitamins and botanical supplements such as hypericum perforatum [St. John's wort]), except for oral contraceptives, within 14 days prior to scheduled administration of the first dose of study drug
- •Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C antibodies or syphilis serum test
研究组 & 干预措施
Cohort 1: Sequence 1 (ABAB)
Participants will receive 10 milligram (mg) loratadine (1*10 mg oral tablet) as Xisimin (Treatment A) on Day 1 of Period 1 and Period 3 and 10 mg loratadine (1*10 mg oral tablet) administered as Clarityne (Treatment B) on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration.
干预措施: Loratadine (Xisimin [Test Treatment]) (Drug)
Cohort 1: Sequence 1 (ABAB)
Participants will receive 10 milligram (mg) loratadine (1*10 mg oral tablet) as Xisimin (Treatment A) on Day 1 of Period 1 and Period 3 and 10 mg loratadine (1*10 mg oral tablet) administered as Clarityne (Treatment B) on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration.
干预措施: Loratadine (Clarityne [Reference Treatment]) (Drug)
Cohort 1: Sequence 2 (BABA)
Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration.
干预措施: Loratadine (Xisimin [Test Treatment]) (Drug)
Cohort 1: Sequence 2 (BABA)
Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration.
干预措施: Loratadine (Clarityne [Reference Treatment]) (Drug)
Cohort 2: Sequence 1 (ABAB)
Participants will receive Treatment A on Day 1 of Period 1 and Period 3 and Treatment B on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration.
干预措施: Loratadine (Xisimin [Test Treatment]) (Drug)
Cohort 2: Sequence 1 (ABAB)
Participants will receive Treatment A on Day 1 of Period 1 and Period 3 and Treatment B on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration.
干预措施: Loratadine (Clarityne [Reference Treatment]) (Drug)
Cohort 2: Sequence 2 (BABA)
Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration.
干预措施: Loratadine (Xisimin [Test Treatment]) (Drug)
Cohort 2: Sequence 2 (BABA)
Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration.
干预措施: Loratadine (Clarityne [Reference Treatment]) (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for Loratadine
时间窗: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Maximum Observed Plasma Concentration (Cmax) of Loratadine
时间窗: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
The Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) for Loratadine
时间窗: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
次要结局
- Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability(From Screening to Day 5 of Period 4 (Approximately 33 days))