HIV
Conditions
Interventions
3 different administrations of one tablet of Stribild.
- breakfast + whole tablet
- breakfast + crushed and suspended tablet
- drip feed + crushed and suspended tablet
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is at least 18 and not older than 55 years at screening.;2. Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to Day 1.;3. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.;4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.;5. Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to day 1. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is in-cluded on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.;6. Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.
Exclusion criteria
Exclusion criteria: 1. Creatinine clearance below 70mL/min.;2. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.;3. Positive HIV test.;4. Positive hepatitis B or C test.;5. Pregnant female (as confirmed by an hCG test performed less than 4 weeks before Day 1 or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterec-tomy, 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 study.;6. Therapy with any drug (for two weeks preceding Day 1), except for acetaminophen.;7. Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disor-ders, renal and hepatic disorders, hormonal disorders (especially dia-betes mellitus), coagulation disorders.;8. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. ;9. History of or current abuse of drugs, alcohol or solvents.;10. Inability to understand the nature and extent of the study and the pro-cedures required.;11. Participation in a drug study within 60 days prior to Day 1.;12. Donation of blood within 60 days prior to Day 1.;13. Febrile illness within 3 days before Day 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim is to asses bioequivalence between the exposure to Elvitegravir, cobicistat, emtricitabine and Tenofovir disoproxil after dosing with a whole tablet (reference) versus a suspended tablet with a standardized breakfast (intervention I) or a bolus drip feed (intervention II). Geometric Mean Ratios and the 90% confidence interval of the pharmacokinetic parameters AUC0-* and Cmax, and the Tmax, and T¬1/2 of intervention I (Standardized breakfast + suspended STB tablet) versus the reference treatment (Standardized breakfast + whole STB tablet). Geometric Mean Ratios and the 90% confidence interval of the pharmacokinetic parameters AUC0-* and Cmax and Tmax and T¬1/2 of intervention II (Bolus drip feed + suspended tablet) versus the reference treatment (Standardized breakfast + whole STB tablet). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary aim is to asses bioequivalence between the exposure to elvitegravir, cobicistat, emtricitabine and Tenofovir disoproxil after dosing with a suspended tablet with a standardized breakfast (intervention I) versus a bolus drip feed (intervention II). Geometric Mean Ratios and the 90% confidence interval of the pharmacokinetic parameters AUC0-*, Cmax,Tmax, T¬1/2 between intervention I (Standardized breakfast + suspended STB tablet) versus intervention II (Bolus drip feed + suspended tablet). | — |
Countries
Netherlands
Outcome results
None listed