Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects
Clinical Study to Evaluate Food-Effect on Pharmacokinetics and Pharmacodynamics of Single Oral Dose of CJ-12420 in Healthy Male Subjects
- Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects.
Secondary
- To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group)
- To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.
調査の概要
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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Seoul、大韓民国
- Asan Medical Center
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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:
- Male volunteers in the age between 20 and 45 years old(inclusive)
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg (inclusive)
Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate)
- 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
- 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
- 45 beats per minute ≤ pulse rate ≤ 95 beats per minute
- Understand the requirements of the study and voluntarily consent to participate in the study
Exclusion Criteria:
Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group.
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary,immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
- History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
The following criteria will be applied ONLY to PD/PK group
- H.pylori positive, as determined by the urea breath test
- Urine cotinine test positive
- Subject who were unable to be applicable for pH meter catheter
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:基礎科学
- 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:Sequence 1
Drug: CJ-12420 200mg Period1: CJ-12420 under fed condition Period2: CJ-12420 under fasting condition
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Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition
他の名前:
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実験的:Sequence 2
Drug: CJ-12420 200mg Period1: CJ-12420 under fasting condition Period2: CJ-12420 under fed condition
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Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition
他の名前:
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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 |
時間枠 |
|---|---|
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Geometric mean ratio and 90% CI for log-transformed AUClast
時間枠:Blood sampling during 24 or 48 hrs after administration
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Blood sampling during 24 or 48 hrs after administration
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Geometric mean ratio and 90% CI for log-transformed Cmax
時間枠:Blood sampling during 24 or 48 hrs after administration
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Blood sampling during 24 or 48 hrs after administration
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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time pH > 4
時間枠:24 hour before and after IP administration
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24 hour before and after IP administration
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Kyun-Seop Bae, MD, Ph.D、Asan Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。