Comparative bioequivalence study of Gabapentin 300 mg capsule of Actoverco and PFIZER PHARMA PFE GmbH

Actoverco Pharmaceutical Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2022年5月2日

试验速览

暂无简介。

•Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2.
•Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
•Subjects with normal ECG and vital signs.
•Subjects who agree with patient consent form.
•Non-smoking at least for 10 hours before study.

•Known hypersensitivity or idiosyncratic reaction to gabapentin or inactive ingredients.
•Subjects with a known history of allergic reaction or drug intolerance.
•History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.
•Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
•Subjects who have a history of alcohol or substance abuse within the last year.
•Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
•A history of difficulty with donating blood or donation of more than 450 ml blood within 60 days prior to the start of the study.

发起方

Actoverco Pharmaceutical Co.