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

NCT01118702 | Completed Phase 1

• 1 other identifier: CR017179
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pharmacokinetics

Keywords

Pharmacokinetic; Methylphenidate; Novo-methylphenidate ER-C; Ritalin-SR; CONCERTA; Plasma profile

Outcome Measures

Primary Outcomes (1)

• The primary objective of this exploratory study is to characterize the plasma concentrations of of methylphenidate from Concerta®, Ritalin-SR® and Novo-Methylphenidate ER-C ® tablets in healthy adult volunteers under fasting conditions.

  Plasma samples will be taken via in-dwelling catheter predose, and 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.

Study Arms (3)

001

ACTIVE COMPARATOR

Concerta one 54mg tablet once

Drug: Concerta

002

ACTIVE COMPARATOR

Ritalin-SR 3-20mg tablets once

Drug: Ritalin-SR

003

ACTIVE COMPARATOR

Novo-Methylphenidate ER-C one 54mg tablet once

Drug: Novo-Methylphenidate ER-C

Interventions

Ritalin-SR DRUG

3-20mg tablets, once

002

Concerta DRUG

one 54mg tablet, once

001

Novo-Methylphenidate ER-C DRUG

one 54mg tablet, once

003

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The volunteer will be assessed against all protocol specified criteria at investigator site: If a female, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives for at least 3 months, contraceptive injections, intrauterine device, contraceptive patch, male partner sterilization) before entry, throughout the study, and 1 week after the completion of the study
• if female, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of each treatment period
• Body mass index (weight \[kg\]/height \[m2\]) between 18 and 30 kg/m2 (inclusive)
• Body weight not less than 50 kg
• Blood pressure (after the patient is sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive

You may not qualify if:

• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, birth control (prescription oral contraceptives, contraceptive injections, intrauterine device, contraceptive patch), and hormonal replacement therapy within 14 days before the first dose of the study drug
• Current, history or a reason to believe a subject has a history of drug or alcohol abuse/dependence according to DSM-IV
• Positive test for drugs of abuse
• Known allergy to the study drug or any of the ingredients in the study drug tablets
• Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half life, whichever is longer, before the first dose of the study drug - a drug's half life is the time that it takes the body to excrete 50% of the drug
• Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
• If a female, breast-feeding or planning to become pregnant during the study or within 60 days of last study drug
• Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies administration
• History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or patient's verbal report
• May not consume food or beverages containing alcohol, grapefruit juice, Seville oranges, or quinine (e.g., tonic water) from 24 hours (72 hours in the case of grapefruit juice and Seville oranges) before each PK sample collection day, until after the last PK sample is collected in each period
• Must refrain from the use of any methylxanthine-containing products, (e.g., chocolate bars or beverages, coffee, teas, or colas) from 48 hours before administration of study drug and during confinement, and when caffeine is allowed, must avoid excessive use of caffeine (i.e., no more than approximately 500 mg/day, as contained in 5 cups of tea or coffee or 8 cans of cola), during the entire study (from screening to end of study)
• May not consume food containing poppy seeds during the study
• Must refrain from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch) throughout the study

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Related Publications (1)

• Shram MJ, Quinn AM, Chen N, Faulknor J, Luong D, Sellers EM, Endrenyi L. Differences in the in vitro and in vivo pharmacokinetic profiles of once-daily modified-release methylphenidate formulations in Canada: examination of current bioequivalence criteria. Clin Ther. 2012 May;34(5):1170-81. doi: 10.1016/j.clinthera.2012.02.010. Epub 2012 Apr 17.

  PMID: 22512898 DERIVED

Related Links

• 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

MeSH Terms

Interventions

Methylphenidate

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 11, 2012

Record last verified: 2012-12