Healthy volunteers with special genotypes MedDRA version: 16.0 Level: LLT Classification code 10053349 Term: Pharmacokinetic study System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Ritalin
Product Name: Ritalin
Pharmaceutical Form: Tablet
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Research Institute of Biological Psychiatry Sct. Hans
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers of both sexes Age > 18 y Caucasian race 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 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any chronic disease Infection within the last 14 days Pregnancy Regular use of medication Smoking Alcohol intake Known allergy to methylphenidate or trandolpril
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Impact of different CES1 genotypes on the metabolism of methylphenidate and trandolapril;Secondary Objective: Can metabolomic profiling reduce the variation in the metabolism of methylphenidate and trandolapril;Primary end point(s): Pharmacokinetic variables after administration of single doses of methylphenidate and trandolapril to healthy volunteers with different CES1 genotypes;Timepoint(s) of evaluation of this end point: Two to 3 days after single dose administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No;Timepoint(s) of evaluation of this end point: No | — |
Countries
Denmark
Outcome results
None listed