Pharmacokinetic study to assess the bioavailability of phenolics from an olive leaf extract - Bioavailability of phenolics from olive leaf extract

Bio-Actor0 个研究点目标入组 31 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•-Female adults between 18 and 75 years old
•-The study will consist of 8 premenopausal and 8 postmenopausal women.
•-Only non*smoking individuals can participate. Non*smoking individuals are hereby defined as individuals who did not smoke during at least 6 months before the start of the study. Individuals who did not smoke for minimum 3 months prior to the study could also be included, upon evaluation and decision by the investigators.
•-The participants are capable and willing to sign the Informed Consent Form at voluntary basis, after having received detailed information.
•-The volunteers are considered healthy based on their medical history as questioned by the investigator during an interview and a general physical examination by the investigator.
•-Female volunteers do not intend to become pregnant prior to or during the study and using adequate contraception.
•-Premenopausal women should be on monophasic oral anti conception and the test day should not be in the pause week or in the first 3 days of pill use, in order to obtain a constant level of estrogen.
•-The postmenopausal women should be at least 2 years post menopausal to ensure a homogeneous population

•-Clinically significant abnormal liver functioning (serum alanine and aspartate aminotransferase).
•-Clinically significant abnormal serum creatinin.
•-Abnormal BMI (i.e. lower than 18 or higher than 30).
•-Use of concomitant medications or supplements.
•-Blood donation during the last 4 weeks prior to the first dosing till 4 weeks after the last dosing.

发起方

Bio-Actor