A Two-Way, Single-Dose, Fasting, Bioequivalence Study of XCalibur Trademark 50mg Capsules versus Viagra Registered Trademark 50mg Film-Coated Tablets in Healthy Male Volunteers

iX Biopharma Ltd.0 个研究点目标入组 48 人开始时间: 2016年12月14日最近更新: 2020年1月13日

试验速览

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•1.In good general health without clinically significant disease, as determined by the Principal Investigator.
•2.Have suitable venous access for blood sampling.
•3.Body mass index (BMI) of 19.0 – 30.0 kg/square meters (inclusive).
•4.Deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.
•5.Has not smoked cigarettes within 6 months of the screening visit.

•1.Past history of hypersensitivity to sildenafil or any of its excipients, or severe allergic or anaphylactic reaction to any other drug.
•2.A medical condition that, in the opinion of the Investigator, may adversely impact the participant’s ability to complete the study (e.g. priapism, easy fainting, abnormal blood pressure, heart disease, retinitis pigmentosa or optic neuropathy or other risk factors of non-arteritic anterior ischaemic optic neuropathy (NAION), or anaemia).
•3.Intake of any prescribed drugs within 2 weeks or Over-The-Counter (OTC)/non-prescribed drugs, vitamins/supplements, or herbal medicines within 1 week of study medication.
•4.Use of drugs with enzyme-inducing properties (such as rifampicin and St John’s Wort) within 3 weeks or 5 half-lives, whichever is greater, prior to treatment period 1 and throughout the study, or any drug known to be a strong inhibitor of CYP3A4 within 5 half-lives of treatment period 1 and throughout the study.
•5.Known or suspected drug or alcohol abuse or dependence.
•6.Positive results on the urine drug screen or breath alcohol test.
•7.Positive for hepatitis C virus (HCV), hepatitis B or human immunodeficiency virus (HIV).
•8.Has received another investigational agent or new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to the Screening visit.

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