A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet

Healthy Volunteer Clinical Trial

Official title:

A Single-Dose, Open-Label, Randomized, Two-Way Crossover Study to Assess the Bioequivalence of Tapentadol Given as Two 25-mg Extended-Release Tamper-Resistant Formulation (TRF) Tablets Relative to One 50-mg Extended-Release TRF Tablet in Healthy Japanese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273506
• Other study ID #: CR017599
• Secondary ID: R331333PAI1062
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2011
• Last updated: March 12, 2012
• Start date: December 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2012
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503) dose administered as two 25-mg ER, TRF tablets relative to one 50-mg ER TRF tablet in healthy Japanese male participants.

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 50-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 25-mg TRF tablets and one 50-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 25-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 50-mg TRF tablet, administered as a single oral dose under fasted condition Each period will be separated by 7

• 14 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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 mm Hg systolic, inclusive, and between 50 and 90 mm Hg diastolic, inclusive

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• tapentadol (CG5503) ER 25-mg TRF
50 mg TRF single oral dose
• tapentadol (CG5503) ER 50-mg TRF
50 mg TRF single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile, as measured by Cmax, tmax, AUC, t1/2, kel, AUMC, and MRT		two days	No
Secondary	Number of participants with adverse events		time of screening to end of treatment (up to 5.5 weeks)	No