Healthy VolunteerPhase 1NCT01273532
A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 50-mg Tablets Relative to One 100-mg Tablet
A Phase 1 study testing tapentadol (CG5503) ER 100-mg TRF and tapentadol (CG5503) ER 50-mg TRF in people with Healthy Volunteer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503) dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in healthy Japanese male participants. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- tapentadol (CG5503) ER 100-mg TRF and tapentadol (CG5503) ER 50-mg TRF
- 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
- Dec 2010to Mar 2011
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese participants who have resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report
- Deemed healthy on the basis of prestudy physical examination, medical history (including smoking habits), 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory parameters (serum chemistry, serology and hematology) performed within 21 days before study drug administration.
- Must not impregnate their partners
- Body mass index (BMI) (weight [kg]/height [m2]) between 18.5 and 25 kg/m2, inclusive, and body weight not less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 100 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive
Who cannot join
- History of seizure disorder or epilepsy or ¿mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
- history of ¿severe traumatic brain injury (consisting of 1 or more of the following: brain contusion
- intracranial hematoma
- or episode(s) of more than 24 hours duration of unconsciousness or posttraumatic amnesia) within 15 years of screening, or history of ¿severe traumatic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness or symptoms suggestive thereof
- History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness
- History of clinically significant allergies, especially known hypersensitivity/intolerance or contraindications to opioids, opioid antagonists (e.g., naloxone), benzodiazepines (e.g., diazepam, clonazepam, lorazepam), any study drug formulation component, any of the excipients of the formulation, or heparin (should the use of a heparin lock be necessary)
- History of, or a reason to believe a participant has a history of lifetime opioid abuse, or drug or alcohol abuse within the past 5 years
About this study
Official title: A Single-Dose, Open-Label, Randomized, Two-Way Crossover Study to Assess the Bioequivalence of Tapentadol Given as Two 50-mg Extended-Release, Tamper-Resistant Formulation (TRF) Tablets Relative to One 100-mg Extended-Release TRF Tablet in Healthy Japanese Male Subjects
The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503) dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in healthy Japanese male participants.
Read the detailed description
This is an open-label (all people know the identity of the intervention), single-center, randomized (the study drug is assigned by chance), 2-way crossover study (participants may receive different interventions sequentially during the trial). All participants will receive a single 100-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 50-mg TRF tablets and one 100-mg TRF tablet. All participants will be randomly assigned to 1 of 2 possible treatment sequences and receive both of the following treatments, 1 in each period:
Treatment A: two tapentadol (CG5503) ER 50-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 100-mg TRF tablet, administered as a single oral dose under fasted condition Each period will be separated by 7 - 14 days
- Conditions
- Healthy Volunteer
- Being tested
- tapentadol (CG5503) ER 100-mg TRF, tapentadol (CG5503) ER 50-mg TRF
- Keywords
- tapentadol, NUCYNTA, CG5503, R331333, pharmacokinetics, healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tapentadol (CG5503) ER 100-mg TRFDrug
100mg TRF single oral dose
tapentadol (CG5503) ER 50-mg TRFDrug
100 mg TRF single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | tapentadol (CG5503) ER 50-mg TRF 100 mg TRF single oral dose Receives: Drug: tapentadol (CG5503) ER 50-mg TRF |
| 002 | Experimental | tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose Receives: Drug: tapentadol (CG5503) ER 100-mg TRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile, as measured by Cmax, tmax, AUC, t1/2, kel, AUMC and MRT
Measured: Two days
Secondary outcomes (1)
Number of participants with adverse events
Measured: Time of screening to end of treatment (up to 5.5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273532
- Sponsor's protocol ID
- CR017602
- Other IDs
- R331333PAI1063
- Status last verified
- Mar 2012
- First submitted
- 7 Jan 2011
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, Two-Way Crossover Study to Assess the Bioequivalence of Tapentadol Given as Two 50-mg Extended-Release, Tamper-Resistant Formulation (TRF) Tablets Relative to One 100-mg Extended-Release TRF Tablet in Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT01273532
- Acronym / sponsor ID
- CR017602
- Conditions
- Healthy Volunteer
- Keywords
- tapentadol, NUCYNTA, CG5503, R331333, pharmacokinetics, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jan 2011 (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.
The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503) dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in healthy Japanese male participants.
Detailed description
This is an open-label (all people know the identity of the intervention), single-center, randomized (the study drug is assigned by chance), 2-way crossover study (participants may receive different interventions sequentially during the trial). All participants will receive a single 100-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 50-mg TRF tablets and one 100-mg TRF tablet. All participants will be randomly assigned to 1 of 2 possible treatment sequences and receive both of the following treatments, 1 in each period:
Treatment A: two tapentadol (CG5503) ER 50-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 100-mg TRF tablet, administered as a single oral dose under fasted condition Each period will be separated by 7 - 14 days
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: tapentadol (CG5503) ER 50-mg TRFtapentadol (CG5503) ER 50-mg TRF 100 mg TRF single oral dose |
| 002 | Experimental | Drug: tapentadol (CG5503) ER 100-mg TRFtapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Japanese participants who have resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report
- Deemed healthy on the basis of prestudy physical examination, medical history (including smoking habits), 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory parameters (serum chemistry, serology and hematology) performed within 21 days before study drug administration.
- Must not impregnate their partners
- Body mass index (BMI) (weight [kg]/height [m2]) between 18.5 and 25 kg/m2, inclusive, and body weight not less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 100 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive
Key exclusion criteria (7 listed)
- History of seizure disorder or epilepsy or ¿mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
- history of ¿severe traumatic brain injury (consisting of 1 or more of the following: brain contusion
- intracranial hematoma
- or episode(s) of more than 24 hours duration of unconsciousness or posttraumatic amnesia) within 15 years of screening, or history of ¿severe traumatic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness or symptoms suggestive thereof
- History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness
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 |
|---|---|---|
| tapentadol (CG5503) ER 100-mg TRF100mg TRF single oral dose | Drug | 002 |
| tapentadol (CG5503) ER 50-mg TRF100 mg TRF single oral dose | Drug | 001 |
Primary outcome
Pharmacokinetic profile, as measured by Cmax, tmax, AUC, t1/2, kel, AUMC and MRT
Time frame: Two days
1 secondary outcome
Number of participants with adverse events
Time frame: Time of screening to end of treatment (up to 5.5 weeks)
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 13 Mar 2012.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tapentadol (CG5503) ER 100-mg TRF and tapentadol (CG5503) ER 50-mg TRF in people with Healthy Volunteer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 7 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 13 Mar 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?
Pharmacokinetic profile, as measured by Cmax, tmax, AUC, t1/2, kel, AUMC and MRT (time frame: Two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2012.