The effect of fluvoxamine and ciprofloxacin on the pharmacokinetics and pharmacodynamics of nabumetone: A three-phase double-blind placebo-controlled cross-over study.
- Conditions
- Pharmacokinetics and pharmacodynamics, healthy volunteer trial
- Registration Number
- EUCTR2008-007647-14-FI
- Lead Sponsor
- Turku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 12
The study will be carried out with 12 healthy volunteers aged 18 to 40 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. A previous history of intolerance to the study drugs or to related compounds and additives.
2. Concomitant drug therapy known to cause enzyme induction or inhibition for at least 30 days prior to the study.
3. Concomitant drug therapy of any kind for at least 14 days prior to the study.
4. Subjects younger than 18 years and subjects over 40 years.
5. Existing or history of asthma, seizures, hematological, endocrine, significant metabolic, significant cardiovascular, psychiatric or gastrointestinal disease, including gut motility disorders or any other significant disease or drug allergy.
6. Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
7. Pregnancy or nursing.
8. Use of hormonal contraception for at least 30 days prior to the study.
9. Donation of blood for 4 weeks prior to and during the study.
10. Special diet or life style conditions which would compromise the conditions of the study or interpretation of the results.
11. Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
12. Smoking for 30 days before the start of the study and during the whole study period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to explore the drug-drug interaction potential between prodrug nabumetone and known CYP1A2-inhibitors fluvoxamine and ciprofloxacin as measured by pharmacokinetics and efficacy of nabumetone. ;Secondary Objective: ;Primary end point(s): Pharmacokinetics of nabumetone. Pharmacodynamics of nabumetone as measured by classical leese frezion test and by formation of thromboxane B2 in vitro .
- Secondary Outcome Measures
Name Time Method