A Single-dose, Single-center, Randomized, Open-label, Two-way Crossover Study in Healthy Adults to Assess the Bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) Versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 54
- 主要终点
- Primary: Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Loratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine
研究概览
简要总结
To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Healthy adult (men or women), age 18 to 55 years inclusive;
- •Body mass index 18.5 to 30.0 kg/m*2 inclusive;
- •Able to read and understand the written informed consent for study-related information and instruction;
- •Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol;
- •Agree not to donate whole blood or components of blood (e.g. plasma, thrombocytes) starting from signing the informed consent form through 30 days after the last study procedure, except for the blood samples collected for this study;
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera), or a double barrier and have a negative pregnancy test at Screening and prior to study drug administration on Day 0 of Dosing Periods 1 and
- •Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy;
排除标准
- •Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal;
- •Known hypersensitivity to any medication (active substances or excipients of the preparations) to be used in the study;
- •Known galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- •Known severe allergies (e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids);
- •Use of, within 1 month before the first study drug administration, systemic or topical medicines or substances which might affect the study objectives, e.g
- •any drug known to induce cytochrome P3A4/5 or P Glycoprotein (e.g. rifampin, carbamazepine, St. John's wort);
- •any drug known to inhibit cytochrome P3A4/5 or P Glycoprotein (e.g. erythromycin, clarithromycin, chloramphenicol, ketoconazole);
- •any drug known to induce cytochrome P2D6 (e.g. rifampin, dexamethasone);
- •any drug known to inhibit cytochrome P2D6 (e.g. cimetidine, desipramine, fluoxetine, metoclopramide);
- •Positive urine pregnancy, urine drug test or Hepatitis B, hepatitis C or HIV tests;
- •Clinically relevant findings in the physical examination, e.g., signs of bleeding diathesis, signs of heart failure, evidence of peripheral circulatory disturbances, and skin abnormalities;
研究组 & 干预措施
Loratadine oral solution/syrup then Claritin peach syrup
Subjects received a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments.
干预措施: Loratadine oral solution (Drug)
Loratadine oral solution/syrup then Claritin peach syrup
Subjects received a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments.
干预措施: Loratadine (Claritin peach syrup) (Drug)
Claritin peach syrup then Loratadine oral solution/syrup
Subjects received a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments.
干预措施: Loratadine oral solution (Drug)
Claritin peach syrup then Loratadine oral solution/syrup
Subjects received a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments.
干预措施: Loratadine (Claritin peach syrup) (Drug)
结局指标
主要结局
Primary: Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Loratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine
时间窗: 0 hour (h) (pre-dose) to 72 h post-dose
Area under the concentration versus time curve from zero to the last data point greater than (\>) LLOQ (AUC\[0-tlast\]) after single dose.
Maximum Observed Concentration (Cmax) of Loratadine in Plasma After Single Oral Dose of Loratadine
时间窗: 0 h (pre-dose) to 72 h post-dose
Maximum observed loratadine concentration in plasma, directly taken from analytical data.
次要结局
- Time to Reach Maximum Concentration (tmax) in Plasma After Single Dose of Loratadine(0 h (pre-dose) to 72 h post-dose)
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Loratadine in Plasma After Single Dose(0 h (pre-dose) to 72 h post-dose)
- Time to Reach Maximum Concentration (tmax) of Desloratadine in Plasma After Single Dose of Loratadine(0 h (pre-dose) to 72 h post-dose)
- Half-Life (t1/2) Associated With the Terminal Slope of Loratadine After Single Dose(0 h (pre-dose) to 72 h post-dose)
- Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Lloratadine in Plasma After Single Oral Dose(0 h (pre-dose) to 72 h post-dose)
- Time of Last Concentration Above the Lower Limit Of Quantitation (LLOQ) of Desloratadine, Directly Taken From Analytical Data (tlast)(0 h (pre-dose) to 72 h post-dose)
- Percentage of Area Under the Concentration Versus Time Curve (AUC) From the Last Calculated Data Point Greater Than Lower Limit of Quantification [LLOQ]) to Infinity (%AUC[tlast-∞]) After Single Oral Administration of Loratadine(0 h (pre-dose) to 72 h post-dose)
- Half-Life (t1/2) Associated With the Terminal Slope of Desoratadine After Single Dose of Loratadine(0 h (pre-dose) to 72 h post-dose)
- Percentage of Area Under the Concentration Versus Time Curve (AUC) from the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) to Infinity (%AUC[tlast-∞]) of Desoratadine After Single Oral Administration of Loratadine(0 h (pre-dose) to 72 h post-dose)
- Total Body Clearance (CL/F) of Loratadine Calculated After its Single Oral Administration(0 h (pre-dose) to 72 h post-dose)
- Maximum Observed Concentration (Cmax) of Desloratadine in Plasma After Single Oral Dose of Loratadine(0 h (pre-dose) to 72 h post-dose)
- Apparent Terminal Rate Constant (λz) of Desoratadine After Single Dose of Loratadine(0 h (pre-dose) to 72 h post-dose)
- Apparent Terminal Rate Constant (λz) of Loratadine After Single Dose(0 h (pre-dose) to 72 h post-dose)
- Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Desoratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine(0 h (pre-dose) to 72 h post-dose)
- Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Desloratadine in Plasma After Single Oral Dose of Loratadine(0 h (pre-dose) to 72 h post-dose)