An Open-Label, Sequential Treatment Study to Assess the Single- and Multiple-Dose Pharmacokinetics of a New Tapentadol Prolonged-Release 250 mg Formulation in Healthy Subjects.
- Conditions
- acute en chronische pijnacute pain / chronic pain
- Registration Number
- NL-OMON32556
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
1. Man or woman, 18 to 55 years of age, inclusive.
2. Signed informed consent.
3. Healthy on the basis of prestudy physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory parameters.
4. Received a thorough explanation of the optional pharmacogenomic research component of the study and was offered the opportunity to participate by signing the separate pharmacogenomic informed consent document.
5. Women must be postmenopausal, surgically sterile or be practicing an effective method of birth control.
6. Women must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening.
7. Body mass index between 20 and 28 kg/m2 inclusive and body weight nog less than 50kg.
8. Blood pressure between 100 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive.
9. Habitually smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration.
1. History of seizure disorder or epilepsy or traumatic brain injury.
2. History of gastrointestinal disease affecting absorption, gastric surgery or
history of or current significant medical illness including (but not limited
to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood
dyscrasias), lipid abnormalities, significant pulmonary disease (including
bronchospastic respiratory 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 subject.
3. History of allergies.
4. History of drug or alcohol abuse.
5. Positive test for drug or alcohol abuse.
6. Donated blood, blood products or loss of blood (> 500 mL) within 2 months before the first administration of study drug.
7. 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 before the first dose of the study drug is scheduled.
8. Women who plan to become pregnant during the study, or who are breast-feeding.
9. Men and women with abnormal hemoglobin concentrations.
10. Subjects who have used prescription medications and/or over-the-counter medication (incl. ibuprofen or herbal medication) within 14 days before first study drug administration, MAOI's and SNRIs within 21 days before first study drug administration, alcohol/grapefruit juice/quinine-containing drinks/seville orange products whithin 24 hours before first study drug administration, methylxanthine-containing products within 48 hours before first study drug administration.
11. Unable to swallow solid, oral dosage forms whole with the aid of water(participants may not chew, divide, dissolve, or crush the study drug).
12. Positive test for HIV and Hepatitis.
13. Preplanned surgery or procedures that would interfere with the conduct of the study.
14. Known or suspected inability to comply with the study protocol.
15. Inability to communicate meaningfully with investigator and staff.
16. Employee of the investigator or study center, as well as family member of the employees or investigator.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Compare how the body processes single and multiple doses of tapentadol for a<br /><br>certain period after taking the tablets. This way absorption, excretion and<br /><br>distribution of the drug in the body is assessed.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Findings of the safety and tolerability.</p><br>