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

NCT02019485 | Completed Phase 1

• 3 other identifiers: CR100457R331333-PAI-1060HP5503/83
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Maximum serum concentration of tapentadol

  Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication)

• Time to reach the observed maximum serum concentration of tapentadol

  Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication

• Area under the serum concentration-time curve of tapentadol from time 0 to the time of the last quantifiable concentration

  Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication

• Area under the serum concentration-time curve of tapentadol from time 0 to infinite time

  Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication

• Percentage of area under the serum concentration-time curve of tapentadol from time 0 to infinite time

  Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication

• Elimination half-life associated with the terminal slope of the semilogarithmic tapentadol concentration-time curve

  Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication

• First-order rate constant associated with the terminal portion of tapentadol concentration curve

  Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication

• Time to last quantifiable serum concentration of tapentadol

  Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication

• Number of participants with adverse events

  Up to end-of-study (Day 3 of last single-dose of study medication)

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

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.

Drug: Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF); Drug: Tapentadol Prolonged-Release Formulation 2 (PR2)

Treatment Sequence BA

EXPERIMENTAL

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.

Drug: Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF); Drug: Tapentadol Prolonged-Release Formulation 2 (PR2)

Interventions

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

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

Treatment Sequence AB; Treatment Sequence BA

Tapentadol Prolonged-Release Formulation 2 (PR2) DRUG

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

Treatment Sequence AB; Treatment Sequence BA

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

US (1)