HealthyPhase 1NCT01981278
A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants
A Phase 1 study testing Tapentadol ER 250-mg TRF tablet and Tapentadol ER 250-mg PR2 tablet in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet in… Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tapentadol ER 250-mg TRF tablet and Tapentadol ER 250-mg PR2 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing to adhere to the prohibitions and restrictions specified in the protocol
- Healthy on the basis of pre-study physical examination, medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters performed within 21 days before study drug administration
- Women must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of each treatment period
- Must agree to use an adequate contraception method and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- Body mass index (BMI) (weight [kg]/height [m2]) between 20 and 28 kg/m2, inclusive, and body weight not less than 50 kg
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, or severe traumatic brain injury within 15 years of screening, or severe traumatic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness or symptoms
- History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection
- History of clinically significant allergies, especially known hypersensitivity/intolerance or contraindications to opioids, opioid antagonists (eg, naloxone), benzodiazepines (eg, diazepam, clonazepam, lorazepam), any study drug formulation component, any of the excipients of the formulation, or heparin
- Women who plan to become pregnant during the study, or who are breast-feeding
- Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess Bioequivalence of a New Tapentadol Extended-Release (TRF) 250-mg Tablet With Respect to a Tapentadol Extended-Release (PR2) 250-mg Tablet Under Fasted Conditions in Healthy Subjects
The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted conditions.
Read the detailed description
This is an open-label (all people know the identity of the intervention), single-center, randomized (the study medication is assigned by chance), 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study of a single dose of 250-mg tapentadol. All participants will receive in randomized order the TRF tablet and PR2 tablet, both as a single dose of 250 mg tapentadol. Approximately 64 participants will be enrolled in the study. The study consists of 3 phases: a screening phase (within 2 to 21 days before the first study drug administration on Day 1 of Period 1), an open-label treatment phase consisting of 2 single-dose treatment periods. Treatment administrations will be separated by a washout period of 7 to 14 days. 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: tapentadol ER 250-mg TRF tablet, administered as a single oral dose under fasted condition and Treatment B: tapentadol ER 250-mg PR2 tablet, administered as a single oral dose under fasted condition. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The duration of participation in the study for an individual participant will be up to 5.5 weeks.
- Conditions
- Healthy
- Being tested
- Tapentadol ER 250-mg TRF tablet, Tapentadol ER 250-mg PR2 tablet
- Keywords
- Healthy, Tapentadol, Bioequivalence, Fasted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol ER 250-mg TRF tabletDrug
Participants will receive single oral dose of tapentadol ER 250-mg TRF tablet on Day 1 of each treatment period.
Tapentadol ER 250-mg PR2 tabletDrug
Participants will receive single oral dose of tapentadol PR2 250-mg tablet on Day 1 of each treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Tapentadol ER 250-mg tamper-resistant formulation (TRF) tablet will be administered as a single oral dose under fasted condition. Receives: Drug: Tapentadol ER 250-mg TRF tablet |
| Treatment B | Experimental | Tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet will be administered as a single oral dose under fasted condition. Receives: Drug: Tapentadol ER 250-mg PR2 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of tapentadol
Cmax is defined as maximum observed analyte concentration.
Measured: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of tapentadol
AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Measured: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of tapentadol
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Measured: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of tapentadol
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Measured: 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 posted11 Nov 2013 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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
- NCT01981278
- Sponsor's protocol ID
- CR100458
- Other IDs
- R331333-PAI-1061
- Status last verified
- Nov 2013
- First submitted
- 5 Nov 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess Bioequivalence of a New Tapentadol Extended-Release (TRF) 250-mg Tablet With Respect to a Tapentadol Extended-Release (PR2) 250-mg Tablet Under Fasted Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01981278
- Acronym / sponsor ID
- CR100458
- Conditions
- Healthy
- Keywords
- Healthy, Tapentadol, Bioequivalence, Fasted
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Nov 2013 (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 bioequivalence (scientific basis on which drugs with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted conditions.
Detailed description
This is an open-label (all people know the identity of the intervention), single-center, randomized (the study medication is assigned by chance), 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study of a single dose of 250-mg tapentadol. All participants will receive in randomized order the TRF tablet and PR2 tablet, both as a single dose of 250 mg tapentadol. Approximately 64 participants will be enrolled in the study. The study consists of 3 phases: a screening phase (within 2 to 21 days before the first study drug administration on Day 1 of Period 1), an open-label treatment phase consisting of 2 single-dose treatment periods. Treatment administrations will be separated by a washout period of 7 to 14 days. 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: tapentadol ER 250-mg TRF tablet, administered as a single oral dose under fasted condition and Treatment B: tapentadol ER 250-mg PR2 tablet, administered as a single oral dose under fasted condition. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The duration of participation in the study for an individual participant will be up to 5.5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Tapentadol ER 250-mg TRF tabletTapentadol ER 250-mg tamper-resistant formulation (TRF) tablet will be administered as a single oral dose under fasted condition. |
| Treatment B | Experimental | Drug: Tapentadol ER 250-mg PR2 tabletTapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet will be administered as a single oral dose under fasted condition. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing to adhere to the prohibitions and restrictions specified in the protocol
- Healthy on the basis of pre-study physical examination, medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters performed within 21 days before study drug administration
- Women must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of each treatment period
- Must agree to use an adequate contraception method and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- Body mass index (BMI) (weight [kg]/height [m2]) between 20 and 28 kg/m2, inclusive, and body weight not less than 50 kg
Key exclusion criteria (5 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, or severe traumatic brain injury within 15 years of screening, or severe traumatic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness or symptoms
- History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection
- History of clinically significant allergies, especially known hypersensitivity/intolerance or contraindications to opioids, opioid antagonists (eg, naloxone), benzodiazepines (eg, diazepam, clonazepam, lorazepam), any study drug formulation component, any of the excipients of the formulation, or heparin
- Women who plan to become pregnant during the study, or who are breast-feeding
- Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
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 ER 250-mg TRF tabletParticipants will receive single oral dose of tapentadol ER 250-mg TRF tablet on Day 1 of each treatment period. | Drug | Treatment A |
| Tapentadol ER 250-mg PR2 tabletParticipants will receive single oral dose of tapentadol PR2 250-mg tablet on Day 1 of each treatment period. | Drug | Treatment B |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of tapentadol
Time frame: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Cmax is defined as maximum observed analyte concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of tapentadol
Time frame: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of tapentadol
Time frame: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of tapentadol
Time frame: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 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 14 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tapentadol ER 250-mg TRF tablet and Tapentadol ER 250-mg PR2 tablet in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
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 5 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 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Maximum Observed Plasma Concentration (Cmax) of tapentadol (time frame: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose). The study lists 4 primary outcomes in all. 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 14 Nov 2013.