The effect of FOsamprenavir/Ritonavir on the pharmacokinetics of a single-dose of the antipsychotic agent olanZApine (FORZA)
- Conditions
- psychosis1003962810047438HIV
- Registration Number
- NL-OMON33257
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Subject is at least 18 and not older than 55 years of age at screening.
2. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes in- cluded.
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
4. Subject is in good age-appropriate health condition as established by medical his-tory, physical examination, electrocardiography, results of biochemistry, haema-tology and urinalysis testing within 4 weeks prior to the first dose. Results of bio-chemistry, haematology and urinalysis testing should be within the laboratory's reference ranges. If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
5. Subject has a normal blood pressure and pulse rate, according to the Investiga-tor's judgement.
1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
2. Positive HIV test.
3. Positive hepatitis B or C test.
4. Pregnant female (as confirmed by an HCG test performed less than 4 weeks be-fore the first dose) or breast-feeding female. Female subjects of childbearing po-tential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, (double) barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the trial.
5. Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
6. Relevant history or presence of pulmonary disorders (especially COPD), cardio-vascular disorders, neurological disorders (especially seizures and migraine), gas-tro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
7. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
8. History of or current abuse of drugs, alcohol or solvents.
9. Inability to understand the nature and extent of the trial and the procedures re-quired.
10. Participation in a drug trial within 60 days prior to the first dose.
11. Donation of blood within 60 days prior to the first dose.
12. Febrile illness within 3 days before the first dose
13. History of narrow-angle glaucoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The influence of fosamprenavir/ritonavir on single-dose pharmacokinetics of<br /><br>olanzapine in healthy volunteers</p><br>
- Secondary Outcome Measures
Name Time Method <p>The safety of fosamprenavir/ritonavir combined with single-dose olanzapine in<br /><br>healthy volunteers</p><br>