Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Topiramate (2 x 25 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Topamax®, Ortho-McNeil Neurologics, Inc.)in Fasted, Healthy, Adult Subjects
Objective:
- Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions.
Clinical Design:
- Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.
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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Missouri
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St, Charles、Missouri、アメリカ、63301
- Gateway Medical Research, Inc.
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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:
- Sex: Male or Female; similar proportions of each preferred.
- Age: At least 18 - 55 years (inclusive).
- Weight: BMI (Body Mass Index) 19 kg/m2 - 30 kg/m2 (inclusive).
Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- Laboratory Tests: Serum pregnancy test (female subjects only), hemoglobin, hematocrit, RBC, WBC, platelet count, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, urinalysis, drugs of abuse, HIV, Hepatitis B, and Hepatitis C will be done for screening purposes.
- Laboratory values which are greater than 20% of the normal range will not qualify unless specifically accepted by a physician who is an investigator or sub-investigator for the clinical trial. Results of a serum pregnancy test (female subjects only), HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.
- Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
- Subjects must read and sign the Consent Form.
Exclusion Criteria:
- Subjects not complying with the above inclusion criteria must be excluded from the study.
In addition, any one (1) of the conditions listed below will exclude a subject from the study:
- History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months.
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
- History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
- History of treatment for asthma within the past five (5) years.
- History of predisposition to renal calculi.
- History of surgery within the past eight (8) weeks.
- History of application of tattoo(s) within the past 30 days.
- History of body piercing(s) within the past 30 days.
- Females who are pregnant or lactating.
- History of hypersensitivity to topiramate or any anticonvulsant medication.
Conditions upon screening which might contraindicate or require that caution be used in the administration of topiramate, including:
- Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg.
- Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the 30 days prior to the initial dosing for this study.
- Subjects who have donated blood within 30 days prior to the initial dosing for this study.
- Subjects who smoke more than 10 cigarettes per day.
- Subjects who do not tolerate venipuncture.
- Subjects who have difficulty fasting or consuming standardized meals.
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:ふるい分け
- 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:Torrent Topiramate
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals)
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Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug.
IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
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アクティブコンパレータ:Topamax
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
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Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug.
IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
|
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 |
---|---|---|
時間 0 から時間 t までの濃度対時間曲線の下の面積 [AUC(0-t)]
時間枠:連続薬物動態血漿濃度は、用量投与前(0時間)および0.5、1、1.5、2、2.5、3、3.5、4、5、6、8、10、12、16、24、36、48および薬投与から72時間後。
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時間 0 から最後の測定可能な濃度の時間までの血漿濃度対時間曲線の下の面積 (t)
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連続薬物動態血漿濃度は、用量投与前(0時間)および0.5、1、1.5、2、2.5、3、3.5、4、5、6、8、10、12、16、24、36、48および薬投与から72時間後。
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時間 0 から無限大 AUC(0-∞) までの血漿濃度対時間曲線の下の領域
時間枠:一連の薬物動態血漿濃度は、投与前(0時間)および0.5、1、1.5、2、2.5、3、3.5、4、5、6、8、10、12、16、24、36、48および投薬から72時間後。
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時間 0 から無限大までの血漿濃度対時間曲線の下の面積。
AUC(0-∞)は、AUC(0-t)に最後に測定可能な血漿濃度と排泄速度定数との比率を加えた合計として計算した。
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一連の薬物動態血漿濃度は、投与前(0時間)および0.5、1、1.5、2、2.5、3、3.5、4、5、6、8、10、12、16、24、36、48および投薬から72時間後。
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Maximum Plasma Concentration (Cmax)
時間枠:serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
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The maximum or peak concentration that the drug reaches in the plasma
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serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
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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
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
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