A Relative Bioavailability Study of 90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Cmax of Fluoxetine.
研究概览
简要总结
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under non-fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years or age or older at the time of dosing. The weight range will not exceed + 15% for height and body frame as per Desirable Weights for Men - 1983 Metropolitan Height and Weight Table or as per Desirable Weights for Women - 1983 Metropolitan Height and Weight Table.
- •Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- •If female and:
- •Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), or
- •Is postmenopausal for at least 1 year, or
- •Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
排除标准
- •Volunteers with a recent history of drug or alcohol addiction or abuse.
- •Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurological system(s) or psychiatric disease (as determined by the clinical investigators).
- •Volunteers whose clinical laboratory test values are outside the acceptable reference range and when confirmed on re-examination are deemed to be clinically significant.
- •Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
- •Volunteers demonstrating a positive drug abuse screen when screened for this study.
- •Female volunteers demonstrating a positive pregnancy screen.
- •Female volunteers who are currently breastfeeding.
- •Volunteers with a history of allergic response(s) to fluoxetine or related drugs.
- •Volunteers with a history of clinically significant allergies including drug allergies.
- •Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- •Volunteers who currently use tobacco products.
- •Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
- •Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for 4 weeks after completing the study.
- •Volunteers who have donated plasma within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for 4 weeks after completing the study.
- •Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
- •Volunteers who report taking any systemic prescription medications in the 14 days prior to Period I dosing.
研究组 & 干预措施
Investigational Test Product
90 mg Fluoxetine Hydrochloride Capsules (Teva)
干预措施: Fluoxetine Hydrochloride (Drug)
Reference Listed Drug
90 mg PROZAC WEEKLY® Capsules (Eli Lilly)
干预措施: PROZAC WEEKLY® (Drug)
结局指标
主要结局
Cmax of Fluoxetine.
时间窗: Blood samples collected over a 25 day period.
Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t of Fluoxetine.
时间窗: Blood samples collected over a 25 day period.
Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
AUC0-inf of Fluoxetine.
时间窗: Blood samples collected over a 25 day period.
Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).
次要结局
- Cmax of Norfluoxetine.(Blood samples collected over a 25 day period.)
- AUC0-t of Norfluoxetine.(Blood samples collected over a 25 day period.)
- AUC0-inf of Norfluoxetine.(Blood samples collected over a 25 day period.)