The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy subjects after administration of one or two oral doses of multiple modified release prototype formulations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
Multiple doses of tolcapone tablets in the fasted state
A single dose of tolcapone modified release prototype in the fasted state
Tolcapone (suspension) in equal divided doses in the fasted state
Quotient Sciences
Ruddington, Nottingham, United Kingdom
Pharmacokinetic Assessment: Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Area under the curve (AUC)
Area under the curve (AUC)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Plasma half-life (t1/2)
Plasma half-life (t1/2)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Relative bioavailability (Frel)
Relative bioavailability (Frel)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Area under the curve (AUC)
Area under the curve (AUC)
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A single dose of tolcapone modified release prototype (optionally two doses or fed state of prior MR prototype)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Plasma half-life (t1/2)
Plasma half-life (t1/2)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Relative Bioavailability (Frel)
Relative Bioavailability (Frel)
Time frame: Pre-dose to 24 hours post-dose
Number of subjects reporting treatment-related Adverse Events (AEs)
Abnormalities in safety laboratory tests, vital signs, electrocardiogram, physical examination that meet the protocol definition will be captured as AEs
Time frame: Screening to 10 days following last dose