A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Fluoxetine From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each Fluoxetine 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.
详细描述
Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 21 days.
Fluoxetine plasma concentrations were determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent is obtained for the study.
- •Age 18 - 55 years
- •Body mass index between 18.5 and 30 kg/m2
- •Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
- •Vital signs without significant deviations.
- •All laboratory screening results are within the normal range or clinically non-significant
排除标准
- •History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk, or interfere with the ability of the subject to complete the study in the investigator's opinion.
- •History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
- •Any confirmed significant allergic reactions against any drug or multiple allergies.
- •Clinically significant illness 28 days before study phase I.
- •Alcohol or any solvent intake.
- •Regular use of medication.
- •Positive urine screening of drugs of abuse.
- •Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
- •History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
- •Blood donation within the past 60 days.
- •Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
研究组 & 干预措施
Test Product (T)
subjects were administered a single hard gelatin capsule of 10 mg Fluoxetine with approximately 240 ml water after an overnight fast of 10 hours
干预措施: Fluoxetine 10 mg capsules (Drug)
Reference Product (R)
subjects were administered a single hard gelatin capsule of 10 mg Fluoxetine with approximately 240 ml water after an overnight fast of 10 hours
干预措施: Prozac® 10 mg capsules (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: (Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
Cmax is observed as the maximum of Fluoxetine peak concentration
Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h)
时间窗: (Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
The AUC (0-72h) is the area under the Fluoxetine plasma concentration with time curve from the time of dosing to the 72-hour sample
次要结局
- Maximum time (Tmax)((Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours)
研究者
Hala Masoud
FRC Technical Director & CEO
Future University in Egypt