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Dataset from An Open Label, Balanced, Randomized, Three-treatment, Three-period, Six-sequence, Cross-over, Single Dose, Comparative Bioavailability Pilot Study of Two Test Formulations of Fixed Dose Combination Capsules of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Manufactured by Piramal Healthcare Limited, India for GSK Comparing With Aspirin® Protect 100 mg Tablets by Bayer Vital GmbH, and Protium® 20 mg Gastro-resistant Tablets by Nycomed GmbH, in Healthy, Adult, Human Subjects, Under Fasting Conditions

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NIAID Data Ecosystem2026-05-02 收录
下载链接:
https://doi.org/10.25934/00002149
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An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over, single dose, comparative bioavailability pilot study under fasting conditions. The treatments will be administered after an overnight fasting of at least 10 hours in each period. Fasting will continue for four hours post-dose, and then meals will be provided at specified intervals. Drinking water will not be permitted one hour before dosing and until one hour post-dose.

本研究为一项开放标签、均衡随机、三治疗、三周期、六序列交叉设计的单剂量空腹条件下对比生物利用度 (bioavailability) 预试验。各试验周期均要求受试者在给药前完成至少10小时的过夜空腹准备;给药后需继续禁食4小时,随后将按照指定时间间隔提供膳食。给药前1小时至给药后1小时内,严禁饮用饮用水。
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2024-11-26
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