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A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy Volunteers

2014-08-27 03:13:53 | BioPortfolio

Summary

This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24 hour period after they take this medication.

Description

The purpose of this study is to measure the blood plasma concentrations of methylphenidate in healthy volunteers for 24 hours after they take three different long acting methylphenidate products. This is a single-centre, randomized (subjects will be assigned a treatment sequence based on chance), open-label (all people involved know the identity of the intervention), single-dose, three-way crossover study (participants may receive different interventions sequentially during the trial) in 30 healthy adult volunteers. Study drug will be taken by mouth with 240mL of room temperature noncarbonated water. Blood sampling will be done via indwelling catheter at pre dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 11, 12, 14, 16, 20 and 24 hours post dose. An indwelling venous catheter is put in place for the 24 hour period to minimize the discomfort of frequent blood sampling. Each patient will receive one dose of each treatment under study in a specific sequence and at specified timepoints. The treatments are: one 54mg Concerta tablet, one 54 mg Novo-methylphenidate ER-C tablet, and 3x20mg Ritalin-SR tablets. The methylphenidate plasma concentrations observed during the 24 hour post-dose time period will be compared for each volunteer and across all volunteers. Adverse events will be monitored from the time the informed consent is signed until the patient completes the last study-related procedure. The investigator must follow all adverse events reported to the investigator to satisfactory resolution or until reaching a clinically stable endpoint. Vital signs will be taken at study entry and before each dose - as well as at specific timepoints over the 24 hour sample period. Clinical labs and EKG will be done at screening and at each 24 hour timepoint.

The official study title is as follows: A Randomized, Open-label, Single-dose, Three-way Crossover Study to Determine the Relative Pharmacokinetic Profile of Oral Doses of CONCERTA Tablets, Ritalin-SR Tablets and Novo-Methylphenidate ER-C Tablets Under Fasted Condition in Healthy Subjects. Methylphenidate is indicated for the treatment of attention deficient hyperactivity disorder in adults, adolescents and children. Each volunteer will receive one 54-mg CONCERTA tablet(once), one 54-mg Novo-Methylphenidate ER-C tablet (once) and three 20mg Ritalin-SR tablets (once) at specified time points in the study. Tablets will be administered as a single oral dose under fasted (minimum 10 hour fast) conditions. Study drug will be administered orally with 240 mL of room temperature noncarbonated water.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Pharmacokinetics

Intervention

Ritalin-SR, Concerta, Novo-Methylphenidate ER-C

Status

Completed

Source

Janssen-Ortho Inc., Canada

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:53-0400

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Medical and Biotech [MESH] Definitions

A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

Agents that aid or increase the action of the principle drug (DRUG SYNERGISM) or that affect the absorption, mechanism of action, metabolism, or excretion of the primary drug (PHARMACOKINETICS) in such a way as to enhance its effects.

Naturally occurring genetic variations associated with drug response (e.g., dosage, extent and rate of metabolic processes). While these variants are not markers for GENETIC PREDISPOSITION TO DISEASE they influence PHARMACOKINETICS and pharmacodynamics and often occur on genes encoding drug metabolism enzymes and transporters (e.g., ANGIOTENSIN CONVERTING ENZYME; CYTOCHROME P-450 CYP2D6).

A novel composition, device, or process, independently conceived de novo or derived from a pre-existing model.

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