Not applicable (including healthy volunteers).
Conditions
Interventions
Trade Name: Implementor
Product Name: Pirlindol
Pharmaceutical Form: Tablet
INN or Proposed INN: PIRLINDOLE
CAS Number: 60762-57-4
Other descriptive name: PIRLINDOLE
Concentration unit: mg milligram(s
Sponsors
TECNIMEDE ? SOCIEDADE TÉCNICO MEDICINAL S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 criterion. 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
Exclusion criteria
Exclusion criteria: 1.- History of allergy, idiosyncrasy or hypersensitivity to drugs. 2.- Heavy consumer of stimulating drinks (> 5 cups of coffee, tea, chocolate or cola drinks per day). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is to assess the proportionality of 3 pirlindole doses (50, 100 and 150 mg) administered orally in healthy volunteers.;Secondary Objective: A secondary objective is to evaluate the safety of 3 pirlindole doses administered in healthy volunteers.;Primary end point(s): The primary pharmacokinetic parameters will be obtained after a non-compartmental approach: AUC0 t , AUC0? and Cmax of pirlindole, after oral administration of 3 doses evaluated (50, 100 and 150 mg). These parameters will be used to assess the linearity of the 3 administered doses from the power model described by Hummel et al. (Hummel, McKendrick et al. 2009).;Timepoint(s) of evaluation of this end point: Blood samples will be taken (10 ml) at the following times: baseline (pre-dose), + 10 '+ 20' + 30' + 45' + 1h, + 1h15 ', + 1h30', 1h45 ',+ 2h, + 3h, 5h +, + 6h, +8 h, +12 h and +24 h post-dose (total 15 points extraction). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: tmax, t1/2, CL/F and V/F of pirlindole after administration of the 3 doses evaluated. It will also assess the safety of 3 doses of pirlindole by adverse effects, vital signs (SBP / DBP and HR) and laboratory parameters.;Timepoint(s) of evaluation of this end point: Blood samples will be taken (10 ml) at the following times: baseline (pre-dose), + 10 '+ 20' + 30' + 45' + 1h, + 1h15 ', + 1h30', 1h45 ',+ 2h, + 3h, 5h +, + 6h, +8 h, +12 h and +24 h post-dose (total 15 points extraction). | — |
Countries
Spain
Contacts
Public ContactSusana Almeida
TECNIMEDE ? SOCIEDADE TÉCNICO MEDICINAL S.A.
Outcome results
None listed