The trial contains only healthy volunteers. The indication for Proscar is benign prostatic hyperplasia and for Movina mild depression.
Conditions
Interventions
Trade Name: Proscar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FINASTERIDE
CAS Number: 98319267
Trade Name: Movina
Pharmaceutical Form: Coated tablet
Sponsors
Department of pharmacy, Uppsala University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Provision of written informed consent 2.Healthy male subject aged between 20 to 45 years. 3.Body mass index between 19-28 kg/m2 4.Clinical normal physical findings in laboratory values judged by the investigator. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Female gender 2.Significant clinical illness or injury, as judged by the investigator, within two weeks before the first administration of the investigational products. 3.History of cardiac, renal, hepatic or significant gastrointestinal disease (that may affect rate and extent of absorption of the investigational product). 4.Hypersensitive stomach 5.History of severe allergy 6.Symptoms/signs of ongoing allergy/hypersensitivity 7.Known allergy to SJW 8.Known hypersensitive reaction to finasteride 9.History of drug addiction and/or alcohol abuse 10.Positive for drug of abuse (urine test) 11.Requirement of concurrent medication during the study. 12.Intake of any prescribed medicine within two weeks before the first administration of the investigational product. 13.Intake of acetylsalicylic acid (ASA) or nonsteroidal anti-inflammatory drugs (NSAIDs) within two weeks before the first administration of the investigational product. 14.Intake of SJW within one month before the first administration of the investigational product. 15.Intake of over-the-counter drugs (including herbals, vitamins and minerals) except for occasional paracetamol, within one week before the first administration of the investigational product. 16.Participation in more than one clinical study with the same drug as in this study, finasteride. 17.Positive HIV or hepatitis B or C tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate if treatment with St John’s wort (SJW) has any influence on the pharmacokinetics and metabolism of finasteride. The pharmacokinetics of finasteride will be investigated by assessment of plasma concentration over time (AUC), maximum plasma concentration (Cmax), plasma half-life (t1/2) and time to Cmax (tmax). ;Secondary Objective: The secondary objective is to study the excretion of finasteride and metabolites into bile and urine. This includes searching for novel metabolites that have not previously been detected. Quantitative determinations of finasteride and previously identified metabolites and qualitative identification of new metabolites in bile and urine will be done. ;Primary end point(s): Variables Pharmacokinetic Concentration of finasteride will be determined in samples of plasma, bile and urine and expressed as AUC, Cmax, t1/2, tmax and fractions of the dose excreted into bile and urine. Quantification of SJW components in plasma, urine and bile and of known finasteride metabolites in bile and urine will be done. Possibilities for identification of previously unidentified finasteride metabolites in bile and urine will be investigated. Effect Effect of finasteride will be investigated by determination of serum concentrations of testosterone and dihydrotestosterone at each sampling point as described above. This will be assessed at both treatment occasions. Shed enterocytes will be collected via the Loc-I-Gut device and the expression of membrane proteins, phase II enzymes and CYP3A4 will be assessed both at protein and mRNA levels. Safety Adverse events occurring during the study, blood pressure, pulse and laboratory values. | — |
Countries
Sweden
Outcome results
None listed