Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of Allegra ® (Containing Fexofenadine Hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - Aventis U.S. LLC, Bridgewater, NJ 08807 in Healthy, Adult, Human Subjects Under Fasting Conditions.
調査の概要
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
-
-
Hyderabad, Andhra Pradesh
-
Balanagar、Hyderabad, Andhra Pradesh、インド、500 037
- Bioserve Clinical Research Private Limited
-
-
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:
i. Provide written informed consent.
ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
iii. Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2.
iv. Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
v. Female Subjects
- of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Exclusion Criteria
i.Incapable of understanding the informed consent.
ii. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
iii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
iv. Oral temperature is below 95.0°F or above 98.6°F.
v. Pulse rate below 50/min or above 100/min.
vi. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
vii. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
viii. Consumption of grapefruit for the past ten days prior to the check-in, in each period.
ix. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
x. Habit of tobacco chewing.
xi. Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
xii. Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
xiii. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
xiv. Clinically significant abnormalities and / or with significant diseases. xv. Confirmed positive in alcohol screening.
xvi. Confirmed positive in selected drug of abuse.
xvii. Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
xviii. Confirmed positive in urine pregnancy test.
xix. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.
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 |
---|---|
実験的:Fexofenadine Hydrochloride Orally Disintegrating
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr.Reddy's Laboratories Ltd
|
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
他の名前:
|
アクティブコンパレータ:ALLEGRA
ALLEGRA orally disintegrating tablets 30 mg of Sanofi Aventis
|
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
他の名前:
|
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 |
---|---|
Area under curve (AUC)
時間枠:Pre-dose (0.0) and 0.167, 0.33, 0.50, 0.75, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.50, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 hrs
|
Pre-dose (0.0) and 0.167, 0.33, 0.50, 0.75, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.50, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 hrs
|
協力者と研究者
捜査官
- 主任研究者:Dr. Vimal Teja, MD、Bioserve Clinical Research Private Limited
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
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
- 671/10
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。