STUDY TO EVALUATE THE PROPORTIONALITY OF 3 ORAL DOSES OF PIRLINDOLE IN HEALTHY VOLUNTEERS.

TECNIMEDE ? SOCIEDADE TÉCNICO MEDICINAL S.A.0 个研究点开始时间: 2013年3月21日最近更新: 2013年5月13日

试验速览

暂无简介。

•1- Subjects of either gender (male or female), with an age between 18 and 45 years.
•2.- Body weight within the normal range (Quetelet index between 18 and 29, expressed as
•weight (kg) / height (m2).
•3.- Medical history, physical examination by organs, both within normal limits.
•4.- No evidence of significant disease (organic or psychiatric) based on the anamnesis taking,
•physical examination and complementary tests.
•5.- Laboratory tests (complete blood count and chemistry) within the normal range,
•according to the normal reference values of the chemistry laboratory of the Hospital de la
•Santa Creu i Sant Pau. Variations may be admitted, in accordance with the CIM?s clinical
•6.- Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and ECG
•record within normal range.
•7.- Participating female volunteers must use contraceptive measures other than oral
•contraceptives.
•8.- To have granted consent to participating in the study, with a written informed consent
•signed by the volunteer prior to inclusion in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.- History of allergy, idiosyncrasy or hypersensitivity to drugs.
•2.- Heavy consumer of stimulating drinks (> 5 cups of coffee, tea, chocolate or cola drinks
•3.- Prior history of alcohol consumption or use or abuse of recreational drugs.
•4.- Use of any medications within 2 weeks prior to taking the study treatment (except for the
•use of acetaminophen in short-term symptomatic treatments), including over-the-counter
•medications and medicinal plants.
•5.- Positive serology for hepatitis B, C, or for the HIV virus.
•6.- A history or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine,
•gastrointestinal, haematological, neurological disease, or other chronic diseases.
•7.- To have undergone surgery during the previous 6 months.
•8.- Smokers.
•9.- Pregnancy or breast-feeding.
•10.- To have participated in another clinical trial during the three months prior to starting the current trial.
•11.- To have donated blood in the 4 weeks prior to starting the study.

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