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A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy Subjects

NCT ID: NCT02019485

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

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The purpose of this study is to evaluate bioequivalence (biological equivalence of two formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg, prolonged-release formulation 2 (PR2) tablet used in healthy participants under fasted (without food) conditions.

Detailed Description

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This is an open-label (all people know the identity of the intervention), 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), single-dose, and single-center study. The study consists of 3 phases: the screening phase, treatment phase, and end-of-study or withdrawal assessment phase. In the treatment phase, participants will receive a single dose of new tapentadol ER 100-mg TRF tablet (Treatment A) and current tapentadol ER 100-mg PR2 (Treatment B) under fasted conditions in 2 treatment sequences (AB and BA). Administration of the study medication will be separated by a washout period (no treatment) of 7 to14 days. Approximately 64 participants will be enrolled in this study. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. The duration of participation in the study for an individual participant will be approximately 5.5 weeks.

Conditions

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Healthy

Keywords

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Healthy Tapentadol Tapentadol extended-release tamper-resistant formulation Tapentadol extended-release prolonged-release formulation Bioequivalence Fasted Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Sequence AB

Participants will receive single dose of new tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF) tablet and later, participants will receive single dose of current tapentadol prolonged-release formulation 2 (PR2) tablet without food. Administration of the study medications will be separated by a washout period (no treatment) of 7 to 14 days.

Group Type EXPERIMENTAL

Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF)

Intervention Type DRUG

Participants will receive a single dose of tapentadol ER TRF 100 mg tablet orally (by mouth) in treatment sequences AB and BA appropriately.

Tapentadol Prolonged-Release Formulation 2 (PR2)

Intervention Type DRUG

Participants will receive a single dose of tapentadol PR2 100 mg tablet orally in treatment sequences AB and BA appropriately.

Treatment Sequence BA

Participants will receive single dose of current tapentadol PR2 tablet and later, participants will receive single dose of new tapentadol ER TRF tablet without food. Administration of the study medication will be separated by a washout period of 7 to 14 days.

Group Type EXPERIMENTAL

Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF)

Intervention Type DRUG

Participants will receive a single dose of tapentadol ER TRF 100 mg tablet orally (by mouth) in treatment sequences AB and BA appropriately.

Tapentadol Prolonged-Release Formulation 2 (PR2)

Intervention Type DRUG

Participants will receive a single dose of tapentadol PR2 100 mg tablet orally in treatment sequences AB and BA appropriately.

Interventions

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Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF)

Participants will receive a single dose of tapentadol ER TRF 100 mg tablet orally (by mouth) in treatment sequences AB and BA appropriately.

Intervention Type DRUG

Tapentadol Prolonged-Release Formulation 2 (PR2)

Participants will receive a single dose of tapentadol PR2 100 mg tablet orally in treatment sequences AB and BA appropriately.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Agrees to protocol-defined use of effective contraception
* Body mass index (BMI) between 20 and 28 kilograms per square meter, inclusive, and body weight not less than 50 kg (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\])
* Habitually 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 medication administration

Exclusion Criteria

* History of seizure disorder or epilepsy or mild or severe traumatic brain injury
* Men with hemoglobin concentrations below 12.5 g/dL or women with hemoglobin concentrations below 11.5 g/dL
* 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
* Positive test for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies
* History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

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Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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R331333-PAI-1060

Identifier Type: OTHER

Identifier Source: secondary_id

HP5503/83

Identifier Type: OTHER

Identifier Source: secondary_id

CR100457

Identifier Type: -

Identifier Source: org_study_id