A Randomized, Open-Label, Single-Dose, Five-Period Crossover, Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg Administered in Healthy Adult Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- area under the plasma drug concentration versus time curve (AUC)
研究概览
简要总结
A Randomized, Open-Label, Single-Dose, Five-Period Crossover, Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg Administered in Healthy Adult Male and Female Subjects
详细描述
Primary:
• To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg and cetirizine HCl oral tablets 10 mg administered under fasted conditions in healthy adult male and female subjects.
Secondary:
- To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted and fed conditions in healthy adult male and female subjects;
- To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted conditions with and without water in healthy adult male and female subjects;
- To determine the relative bioavailability of a single oral dose of cetirizine HCl Gummy 10 mg administered under fasted conditions and chewed or swallowed whole in healthy adult male and female subjects.
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
- •Are capable of giving informed consent and complying with study procedures;
- •Male or female, 18 to 55 years of age, inclusive, at date of consent;
- •Body mass index (BMI) ≥ 18.0 to ≤ 32.0 kg/m2 and total body weight > 50 kg (110 lbs.) at Screening;
- •All female subjects must have a negative pregnancy test at Screening and at each Check-in Visit; and one of the following:
- •Using a medically acceptable form of birth control for at least 1 month prior to first dose [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), intrauterine device, or a double barrier method (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
- •Documented as surgically sterile by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/tubal occlusion) at least 6 months prior to the first dose;
- •Postmenopausal (no menstruation for a minimum of 12 months and confirmed by FSH and estradiol at Screening);
- •Medically healthy based on medical history, vital sign measurements, clinical laboratory test results, and physical examination;
- •Non-smokers (including nicotine-containing products) for at least 6 continuous months prior to the first dose.
- •Be willing and able to consume all contents of the standardized high calorie, high fat breakfast within 30 minutes prior to dosing.
排除标准
- •Females who are pregnant, lactating, or planning to become pregnant during the study;
- •Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder;
- •Subjects with history of hypersensitivity to cetirizine or hydroxyzine, or any component of the test and reference formulations;
- •Subjects who test positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody;
- •Subjects who test positive at Screening or at Check-in for alcohol and/or drugs of abuse;
- •Subjects who donated ≥ 500 mL of blood within 56 days prior to the first dose of study drug or ≥ 50 mL and ≤ 499 mL of blood within 30 days or plasma (e.g. plasmapheresis) within 14 days prior to the first dose of study drug;
- •Use of prescription or non-prescription drugs, dietary supplements, or herbal supplements at the time of Screening and within 14 days prior to the first dose of the study drug;
- •Subjects who have a history of difficulty in donating blood or difficulty with phlebotomy procedures, and poor venous access;
- •Subjects who have participated in another clinical trial within 30 days prior to the first study period;
- •Member or first-degree relative of study staff or the Sponsor directly involved in the study;
- •Any condition which in the opinion of Investigator would interfere with the subject's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the subject if he or she took part in the trial.
研究组 & 干预措施
A: Test under Fasted Condition
Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions
干预措施: cetirizine HCl Gummy (Drug)
B: Reference under Fasted Condition
Reference: Single oral dose of cetirizine HCl oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions
干预措施: Zyrtec tablet 10mg (Drug)
C: Test under Fed Condition
Test: Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions
干预措施: cetirizine HCl Gummy (Drug)
D: Test under Fasted Condition with No Water
Single oral dose of cetirizine HCl Gummy 10 mg, chewed, administered with no water, under fasted conditions
干预措施: cetirizine HCl Gummy (Drug)
E: Test Swallowed Whole with Water, under Fasted Condition
Single oral dose of cetirizine HCl Gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions
干预措施: cetirizine HCl Gummy (Drug)
结局指标
主要结局
area under the plasma drug concentration versus time curve (AUC)
时间窗: 2 months
AUC will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ). AUC will be calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0 ∞).
maximum plasma cetirizine concentration (Cmax)
时间窗: 2 months
PK blood samples to measure plasma concentrations of cetirizine will be collected by direct venipuncture or by use of an indwelling cannula. Blood will be collected into tubes containing K2EDTA for determination of plasma cetirizine concentration at time 0 (within 60 minutes pre-dose), 10, 20 minute post-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 hours post-dose. Plasma cetirizine concentrations will be listed at each time point by subject and summarized by treatment at each time point using descriptive statistics (n, mean, standard deviation (SD), Coefficient of variation (CV%), median, minimum and maximum values). Pharmacokinetic calculations will be performed based on actual time of blood sample collection, using non-compartmental methods with Phoenix WinNonlin Version 8.1 (Certara USA, Inc., Princeton, New Jersey, USA). Plots of mean concentrations of plasma cetirizine versus time will be generated and Cmax will be generated from the plot.
次要结局
- time to Cmax (Tmax)(2 months)
- elimination half-life (t½)(2 months)
- terminal elimination rate constant (Kel).(2 months)