PharmacokineticsPhase 1NCT01118702
A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy Volunteers
A Phase 1 study testing Ritalin-SR, Concerta and Novo-Methylphenidate ER-C in people with Pharmacokinetics, run by Janssen-Ortho Inc., Canada.
Trial summary
This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24 hour period after they take this medication. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Ritalin-SR, Concerta and Novo-Methylphenidate ER-C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
Official title: 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-CTablets Under Fasted Condition in Healthy Subjects
This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24 hour period after they take this medication.
Read the detailed 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.
- Conditions
- Pharmacokinetics
- Being tested
- Ritalin-SR, Concerta, Novo-Methylphenidate ER-C
- Keywords
- Pharmacokinetic, Methylphenidate, Novo-methylphenidate ER-C, Ritalin-SR, CONCERTA, Plasma profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritalin-SRDrug
3-20mg tablets, once
ConcertaDrug
one 54mg tablet, once
Novo-Methylphenidate ER-CDrug
one 54mg tablet, once
| Study group | Role | What they receive |
|---|---|---|
| 001 | Active comparator | Concerta one 54mg tablet once Receives: Drug: Concerta |
| 002 | Active comparator | Ritalin-SR 3-20mg tablets once Receives: Drug: Ritalin-SR |
| 003 | Active comparator | Novo-Methylphenidate ER-C one 54mg tablet once Receives: Drug: Novo-Methylphenidate ER-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Ortho Inc., Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Ortho Inc. Clinical Trial, Study director, Janssen-Ortho Inc., Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118702
- Sponsor's protocol ID
- CR017179
- Other IDs
- CR017179
- Status last verified
- Dec 2012
- First submitted
- 5 May 2010
- Last updated
- 11 Dec 2012
- Results posted
- No
Publications
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.
PubMed 22512898
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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-CTablets Under Fasted Condition in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01118702
- Acronym / sponsor ID
- CR017179
- Conditions
- Pharmacokinetics
- Keywords
- Pharmacokinetic, Methylphenidate, Novo-methylphenidate ER-C, Ritalin-SR, CONCERTA, Plasma profile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen-Ortho Inc., CanadaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Study completion
- Jun 2010 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24 hour period after they take this medication.
Detailed 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Active comparator | Drug: ConcertaConcerta one 54mg tablet once |
| 002 | Active comparator | Drug: Ritalin-SRRitalin-SR 3-20mg tablets once |
| 003 | Active comparator | Drug: Novo-Methylphenidate ER-CNovo-Methylphenidate ER-C one 54mg tablet once |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritalin-SR3-20mg tablets, once | Drug | 002 |
| Concertaone 54mg tablet, once | Drug | 001 |
| Novo-Methylphenidate ER-Cone 54mg tablet, once | Drug | 003 |
Primary outcome
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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Derived from this study: PubMed 22512898Shram 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.
- 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 SubjectsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Ortho Inc. Clinical Trial study director
Janssen-Ortho Inc., Canada
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ritalin-SR, Concerta and Novo-Methylphenidate ER-C in people with Pharmacokinetics, run by Janssen-Ortho Inc., Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01118702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.