A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
2013年3月19日 更新者:Teva Branded Pharmaceutical Products R&D, Inc.
A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of Two 45-mg and One 90-mg Hydrocodone Bitartrate Extended-Release Tablet
The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
54
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Texas
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Austin、Texas、アメリカ
- Teva Investigational Site 10470
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~45年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Treatment Group AB
Subjects in this group will receive study drug in the following sequence:
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Each subject will receive 1 treatment during each administration period.
Subjects will receive each of the 2 treatments once.
There will be a minimum 14-day washout period between the 2 administrations of study drug.
Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
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実験的:Treatment Group BA
Subjects in this group will receive study drug in the following sequence:
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Each subject will receive 1 treatment during each administration period.
Subjects will receive each of the 2 treatments once.
There will be a minimum 14-day washout period between the 2 administrations of study drug.
Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Maximum observed plasma drug concentration (Cmax)
時間枠:Up to 72 hrs after each dose of study drug
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To assess the bioequivalence between 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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Area under the plasma drug concentration by time curve AUC0-∞
時間枠:Up to 72 hrs after each dose of study drug
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To assess bioequivalence between two 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Time to maximum observed plasma drug concentration (tmax)
時間枠:Up to 72 hrs after each dose of study drug
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To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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AUC from time 0 to 72 hours after study drug administration (AUC0-72)
時間枠:Up to 72 hrs after each dose of study drug
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To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)
時間枠:Up to 72 hrs after each dose of study drug
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To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞)
時間枠:Up to 72 hrs after each dose of study drug
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To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½)
時間枠:Up to 72 hrs after each dose of study drug
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To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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Recording of Adverse Events
時間枠:Adverse events will be collected for the duration of the study which is approximately 7 weeks
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To characterize the safety of the hydrocodone bitartrate extended-release tablet in healthy naltrexone-blocked subjects.
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Adverse events will be collected for the duration of the study which is approximately 7 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年1月1日
一次修了 (実際)
2013年1月1日
研究の完了 (実際)
2013年2月1日
試験登録日
最初に提出
2013年1月10日
QC基準を満たした最初の提出物
2013年1月14日
最初の投稿 (見積もり)
2013年1月17日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年3月20日
QC基準を満たした最後の更新が送信されました
2013年3月19日
最終確認日
2013年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
痛みの臨床試験
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