An escalating single oral dose trial investigating the safety, tolerance, pharmacokinetics and pharmacodynamics of orally administered Org 201745-0 in healthy sterilized women with normal ovulatory cycles - Single oral dose of Org 201745-0

Akzo Nobel (Organon)Orion Pharma0 个研究点目标入组 48 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•- Healthy sterilized females with normal ovulatory cycles (i.e. a mean cycle length between 24 and 35 days and an intra-individual variation of plus or minus 3 days, but never outside the 24-35 days range.)
•- Age between 18-50 years inclusive at the time of the first dosing administration.
•- BMI 18.0-30.0 kg/m2 (extremes included).
•- Good physical and mental health
•- Ability and willingness to sign the Informed Consent Form prior to screening evaluations.

•Contradictions for contraceptive steriods;
•History of trombosis or an ilness related to trombosis;
•an elevated risk of getting trombosis;
•History of drugs and/or alcohol abuse;
•Surgary within the last 3 months;
•use of medication within 14 days prior to study start (exeption of ibuprofen);
•if you participated in another trial within 3 months before the start of this study;
•if you donated blood within 3 months before the start of the study;
•if you are hepatitis B, C or HIV positive;
•if you are not suitable according to the principal investigator to participate in this trial.

发起方

Akzo Nobel (Organon)Orion Pharma