An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Pregabalin 75 mg Duloxetine as delayed release 30 mg capsule of Signature Phytochemical Industries in comparison with Pregalin D 75/30 Pregabalin 75 mg Duloxetine as delayed release) 30 mg Capsule of Torrent Pharma Ltd., in healthy adult human subjects under fasting condition.

Signature Phytochemical Industries0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1.Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
•2.Willing to be available for the entire study period and to comply with protocol requirements.
•3.Male subjects have to agree to use condoms during sexual intercourse with a woman of childbearing potential for at least 10 weeks (one complete sperm cycle) after the last dose of study drug.
•4.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.

•1.Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs.
•2.History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
•3.History of severe infection or major surgery in the past 6 months.
•4.History of Minor surgery or fracture within the past 3 months.

发起方