Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects (RTV)
An Open-label, Randomized Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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-
Zhejiang
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Hangzhou、Zhejiang、中国、310003
- First affiliated Hospital of Zhejiang University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy adult volunteers of 18-45 years old.
- Male (weight ≥50kg);Female (weight ≥45kg)
- Body mass index (BMI) between 19~28 kg/m2;
- In good health as determined by a physician/investigator based on medical history, vital signs, electrocardiogram (ECG), laboratory tests and physical examination findings at screening;
- Female participant with negative result of HCG test and agrees to use adequate contraception from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- Male participant agrees to use adequate contraception and have no plan to donate sperm from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress;
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
Exclusion Criteria:
- Subject who cannot tolerate venipuncture.
- Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
- Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
- Abnormal results of physical examination (hematology, urine test,blood biochemistry etc.), vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) or x-ray with clinical significance.
- A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test;
- Women who is during lactation, pregnancy or plan to have baby recently.
- Women with positive result of HCG test.
- Subject who refuse to use adequate contraception from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week) within 6 months preceding this study or is unwilling to agree to abstain from alcohol and drugs throughout the study;
- Heavy smokers (>5 cigarettes per day) within 6 months preceding this study or is unwilling to agree to abstain from smoking throughout the study;
- Positive test results for alcohol or drug at Screening;
- History of hospitalization or surgery within 3 months preceding this study.
- Blood donation within the last 2 months (>= 400 ml), or have a plan to donate blood within 1 month after this study;
- Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.
- Participation in another study with an investigational drug within the last 3 months preceding this study;
- History of gastrointestinal surgery, vagotomy, enterotomy or other surgery that may influence gastrointestinal motility,PH or gastrointestinal absorption.
- Intake of grapefruit or orange (or other food containing grapefruit or orange) 3 days previous to the start of the study. Intake of tea,coffee or other drink containing coffee more than 1L per day.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive Ritonavir.
研究計画
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:fasting group
During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fasting condition. For group1: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group2: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg |
During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .
During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .
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実験的:Fed group
During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fed condition. For group3: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group4: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg |
During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .
During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .
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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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Cmax
時間枠:36 hours post-dose on Day 1,7
|
Maximum Observed Plasma Concentration for ritonavir Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. |
36 hours post-dose on Day 1,7
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Tmax
時間枠:36 hours post-dose on Day 1,7
|
Time to Reach the Maximum Plasma Concentration
|
36 hours post-dose on Day 1,7
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AUC(0-inf)
時間枠:Time Frame: 36 hours post-dose on Day 1,7
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Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir
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Time Frame: 36 hours post-dose on Day 1,7
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AUC(0-36h)
時間枠:36 hours post-dose on Day 1,7
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Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir
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36 hours post-dose on Day 1,7
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ZYYY-LTNW-BE-2017-05-2
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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