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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02019485

Run by

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

People needed

64

Starts

2010-07-01

Expected to finish

2010-08-01

Last updated by the study team

2013-12-24

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.