69 healthy male subjects, age 18-45 undergo a laboratory stress test (TSST)
Conditions
Interventions
Trade Name: Tafil
Product Name: Tafil
Pharmaceutical Form: Capsule*
INN or Proposed INN: Alprazolam
CAS Number: 28981-97-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
daacro - diagnostic assessment and clinical research organization
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male healthy subjects age 18-45 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: Subject .. ... is smoking more than 5 cigarettes; ... is familiar with the TSST; ... has a history of or a present mental illness; ... uses any systemic medication or recent immunization considered to affect the endocrine or behavioral measures o uses psychoactive drugs of any sort within the four weeks before testing; ... participates in any other clinical study; ... is assessed physically unhealthy (medical and laboratory examination); ... has a contraindication for intake of either Alprazolam or Flupentixol;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Sensitivity of the TSST in the assessment of anxiolytic properties of drugs (Tafil and Fluanxol);Secondary Objective: Effects of anxiolytics on physiological and psychological outcome measures in the TSST;Primary end point(s): Completion of the TSST protocol; One hour survey after the stress test; Final medical check; | — |
Countries
Germany
Outcome results
None listed