HealthyPhase 1NCT01900587

A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet

A Phase 1 study testing Tapentadol ER Tamper-resistant Formulation (TRF) and Tapentadol ER Prolonged-Release 2 (PR2) in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER) tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release formulation 2 (PR2) tablet, in healthy participants. 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 Tamper-resistant Formulation (TRF) and Tapentadol ER Prolonged-Release 2 (PR2)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 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

Participants deemed healthy on the basis of pre-study 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
Female participants must be post-menopausal, surgically sterile, or, if of childbearing potential/sexually active, be practicing an effective method of birth control throughout the study. Women must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on Day -1 of each treatment period. Men must not impregnate their partners
Participants with body mass index (BMI) (weight [kilogram {kg}]/height [meter {m}^2]) in-between 20 to 28 kg/m^2, inclusive, and body weight not less than 50 kg
Participants with blood pressure between 100 and 140 millimeters of mercury (mmHg) systolic, inclusive, and between 50 and 90 mmHg diastolic
Participants who smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the first study drug administration

Who cannot join

Participants with 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 squealed suggesting transient changes in consciousness or symptoms
Participants with 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, or any other illness that the Investigator considers should exclude the participants
Participants who received an experimental drug or used an experimental medical device within 30 days or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled or to participate in an investigational drug study for at least 60 days after completion of the study
Participants who have positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, or barbiturates at Screening or Day -1 of each treatment period
Participants who donated blood or blood products or had substantial loss of blood (greater than 500 milliliter) within 2 months before the first administration of study drug

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Lincoln, Nebraska

Other trials in United States

About this study

Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess Bio-equivalence of a New Tapentadol Extended-Release (TRF) 50-mg Tablet With Respect to a Tapentadol Extended-Release (PR2) 50-mg Tablet Under Fasted Conditions in Healthy Subjects

Read the detailed description

This is a single-dose, open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-centre, randomized (like the flip of a coin; 50/50 chance of receiving a study treatment), and 2-way crossover (groups of participants receive two or more interventions in a particular order) study of a single-dose tapentadol in healthy participants under fasted conditions. The study consists of 3 parts: Screening (2 to 21 days before the study commences), Open-label Treatment (single-dose treatment on Day 1 of each period separated with wash-out period of 7 to 14 days) and End of study (Day 3 of treatment Period 2). The duration of participation in the study for an individual participant will be up to 5.5 weeks (including Screening). Participants will be randomly assigned to one of the 2 treatment sequence groups. Participants assigned to the first treatment sequence will receive tapentadol TRF 50 milligram (mg) tablet, and after a washout period, participants will receive tapentadol PR2 50-mg tablet. Participants assigned to the second treatment sequence will receive tapentadol PR2 50-mg tablet, and after washout period, participants will receive tapentadol TRF 50-mg tablet. Bio-equivalence will be primarily evaluated by pharmacokinetics parameters. Participant's safety will be monitored throughout the study.

Conditions: Healthy
Being tested: Tapentadol ER Tamper-resistant Formulation (TRF), Tapentadol ER Prolonged-Release 2 (PR2)
Keywords: Healthy, Bio-equivalence, Tapentadol extended release, Tamper-resistant formulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tapentadol ER Tamper-resistant Formulation (TRF)Drug
Single dose of tapentadol ER 50 milligram (mg), will be administered under fasted condition.
Tapentadol ER Prolonged-Release 2 (PR2)Drug
Single dose of tapentadol ER 50 milligram (mg), prolonged release tablet will be administered under fasted condition.

Study groups in NCT01900587
Study group	Role	What they receive
Tapentadol Extended release (ER) TRF then tapentadol ER PR2	Experimental	Single dose of tapentadol ER 50 milligram (mg), tamper-resistant formulation (TRF) tablet will be administered under fasted condition in first treatment period; after that in second treatment period, single-dose of tapentadol ER 50 mg, prolonged released (PR2) tablet will be administered under fasted condition. A washout period of 7 to 14 days will be maintained between each treatment period. Receives: Drug: Tapentadol ER Tamper-resistant Formulation (TRF); Drug: Tapentadol ER Prolonged-Release 2 (PR2)
Tapentadol ER PR2 then tapentadol ER TRF	Experimental	Single dose of tapentadol ER 50 milligram (mg), PR2 tablet will be administered under fasted condition in first treatment period; after that in second treatment period, single-dose of tapentadol ER 50 mg, TRF tablet will be administered under fasted condition. A washout period of 7 to 14 days will be maintained between each treatment period. Receives: Drug: Tapentadol ER Tamper-resistant Formulation (TRF); Drug: Tapentadol ER Prolonged-Release 2 (PR2)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Serum Concentration (C[max])
The C(max) is the maximum serum concentration which will be observed at the defined time points.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [infinity])
The AUC (infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [last])
The AUC (last) is the area under the serum concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

Secondary outcomes (6)

Time to Reach the Maximum Serum Concentration (T[max])
The T[max] is time to reach the observed maximum serum concentration.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Percentage of AUC(infinity)
Percentage of AUC(infinity) is calculated as (AUC[infinity] minus AUC[last] divided by AUC[infinity]) multiplied by 100.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Elimination half-life period (t1/2)
Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z).
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Terminal slope (Lambda [z])
Terminal slope is defined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Time to Last Quantifiable Serum Concentration (T[last])
The T(last) is the time to reach last quantifiable serum concentration.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Relative Bioavailability of Tapentadol (F[rel])
The F(rel) of tapentadol is calculated as the Area Under the Serum Concentration-Time Curve (AUC) and Cmax ratios of the two Treatments(that is, treatment effect).
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Aug 2010

First posted16 Jul 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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01900587
Sponsor's protocol ID: CR100456
Other IDs: R331333-PAI-1059
Status last verified: Oct 2013
First submitted: 12 Jul 2013
Last updated: 1 Nov 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 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 Bio-equivalence of a New Tapentadol Extended-Release (TRF) 50-mg Tablet With Respect to a Tapentadol Extended-Release (PR2) 50-mg Tablet Under Fasted Conditions in Healthy Subjects
ClinicalTrials.gov ID: NCT01900587
Acronym / sponsor ID: CR100456
Conditions: Healthy
Keywords: Healthy, Bio-equivalence, Tapentadol extended release, Tamper-resistant formulation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 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: 16 Jul 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tapentadol Extended release (ER) TRF then tapentadol ER PR2	Experimental	Drug: Tapentadol ER Tamper-resistant Formulation (TRF), Drug: Tapentadol ER Prolonged-Release 2 (PR2)Single dose of tapentadol ER 50 milligram (mg), tamper-resistant formulation (TRF) tablet will be administered under fasted condition in first treatment period; after that in second treatment period, single-dose of tapentadol ER 50 mg, prolonged released (PR2) tablet will be administered under fasted condition. A washout period of 7 to 14 days will be maintained between each treatment period.
Tapentadol ER PR2 then tapentadol ER TRF	Experimental	Drug: Tapentadol ER Tamper-resistant Formulation (TRF), Drug: Tapentadol ER Prolonged-Release 2 (PR2)Single dose of tapentadol ER 50 milligram (mg), PR2 tablet will be administered under fasted condition in first treatment period; after that in second treatment period, single-dose of tapentadol ER 50 mg, TRF tablet will be administered under fasted condition. A washout period of 7 to 14 days will be maintained between each treatment period.

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participants deemed healthy on the basis of pre-study 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
Female participants must be post-menopausal, surgically sterile, or, if of childbearing potential/sexually active, be practicing an effective method of birth control throughout the study. Women must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on Day -1 of each treatment period. Men must not impregnate their partners
Participants with body mass index (BMI) (weight [kilogram {kg}]/height [meter {m}^2]) in-between 20 to 28 kg/m^2, inclusive, and body weight not less than 50 kg
Participants with blood pressure between 100 and 140 millimeters of mercury (mmHg) systolic, inclusive, and between 50 and 90 mmHg diastolic
Participants who smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the first study drug administration

Key exclusion criteria (5 listed)

Participants with 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 squealed suggesting transient changes in consciousness or symptoms
Participants with 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, or any other illness that the Investigator considers should exclude the participants
Participants who received an experimental drug or used an experimental medical device within 30 days or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled or to participate in an investigational drug study for at least 60 days after completion of the study
Participants who have positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, or barbiturates at Screening or Day -1 of each treatment period
Participants who donated blood or blood products or had substantial loss of blood (greater than 500 milliliter) within 2 months before the first administration of study 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
Tapentadol ER Tamper-resistant Formulation (TRF)Single dose of tapentadol ER 50 milligram (mg), will be administered under fasted condition.	Drug	Tapentadol ER PR2 then tapentadol ER TRF, Tapentadol Extended release (ER) TRF then tapentadol ER PR2
Tapentadol ER Prolonged-Release 2 (PR2)Single dose of tapentadol ER 50 milligram (mg), prolonged release tablet will be administered under fasted condition.	Drug	Tapentadol ER PR2 then tapentadol ER TRF, Tapentadol Extended release (ER) TRF then tapentadol ER PR2

Primary outcome

Maximum Serum Concentration (C[max])
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
The C(max) is the maximum serum concentration which will be observed at the defined time points.
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [infinity])
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
The AUC (infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [last])
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
The AUC (last) is the area under the serum concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.

6 secondary outcomes

Time to Reach the Maximum Serum Concentration (T[max])
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Percentage of AUC(infinity)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Elimination half-life period (t1/2)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Terminal slope (Lambda [z])
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Time to Last Quantifiable Serum Concentration (T[last])
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication
Relative Bioavailability of Tapentadol (F[rel])
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

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 1 Nov 2013.
A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) TabletLink 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.

Johnson & Johnson Pharmaceutical R&D, L.L.C Clinical Trial study director

Johnson & Johnson Pharmaceutical R&D, L.L.C

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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 Serum Concentration (C[max]) (time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication). The study lists 3 primary outcomes in all. 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 NCT01900587.

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 1 Nov 2013.