NCT01758978已完成1 期
A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of Two 30-mg and One 60-mg Hydrocodone Bitartrate Extended-Release Tablet
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Maximum observed plasma drug concentration (Cmax)
研究概览
简要总结
The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release tablet.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent is obtained.
- •The subject can read, speak, and write in English.
- •The subject is a man or woman 18 through 45 years of age, with a body mass index (BMI) of 20.0 to 30.0 kg/m2, inclusive.
- •The subject is in good health as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, urinalysis, and serology.
- •Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, be using an acceptable method of contraception, and agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include abstinence or an intrauterine device (known to have a failure rate of less than 1% per year).
- •The subject has a negative alcohol test and urine drug screen (UDS).
- •The subject must be willing and able to comply with study restrictions and to remain at the study center for the required duration of each study drug period during the study.
排除标准
- •The subject has any clinically significant uncontrolled medical conditions (treated or untreated).
- •The subject has a clinically significant deviation from normal in ECG or physical examination findings, as determined by the investigator or the medical monitor.
- •The subject has habitually consumed, within the past 2 years, more than 21 units of alcohol per week, or has a history of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision (DSM-IV-TR, American Psychiatric Association 2000). NOTE: A unit of alcohol is equal to 1 ounce of hard liquor, 5 ounces of wine, or 8 ounces of beer.
- •The subject is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
- •The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal (GI) surgery; a history of appendectomy is allowed).
- •The subject has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug.
- •The subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, their related compounds, or to any metabolites, or naltrexone, or any compound listed as being present in a study formulation.
- •Other exclusion criteria apply.
研究组 & 干预措施
Treatment Group AB
Experimental
Subjects in this group will receive study drug in the following sequence:
- Treatment A: two 30-mg hydrocodone bitartrate extended-release tablets (reference)
- Treatment B: one 60-mg hydrocodone bitartrate extended-release tablet (test).
干预措施: a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B). (Drug)
Treatment Group BA
Experimental
Subjects in this group will receive study drug in the following sequence:
- Treatment B: one 60-mg hydrocodone bitartrate extended-release tablet (test).
- Treatment A: two 30-mg hydrocodone bitartrate extended-release tablets (reference).
干预措施: a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B). (Drug)
结局指标
主要结局
Maximum observed plasma drug concentration (Cmax)
时间窗: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To assess the bioequivalence between 30-mg tablets and one 60-mg tablet of the hydrocodone bitartrate extended-release tablet.
Area under the plasma drug concentration by time curve AUC 0-∞
时间窗: Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.
To assess bioequivalence between two 30-mg tablets and one 60-mg tablet of the hydrocodone bitartrate extended-release tablet.
次要结局
- Time to maximum observed plasma drug concentration (tmax)(Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.)
- AUC from time 0 to 72 hours after study drug administration (AUC0-72)(Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.)
- AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)(Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.)
- Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞)(Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.)
- Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½)(Approximately 5 minutes prior to study drug administration up to 72 post study drug administration.)
- Recording of Adverse Events(From ICF signing to 48-72 hours after discharge from the study center following the last administration of the hydrocodone bitartrate extended-release tablet.)
研究者
研究点 (1)
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