HIV infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: Raltegravir
Product Code: MK-0518
Pharmaceutical Form: Tablet
Trade Name: Lamictal / Lamotrigine
Pharmaceutical Form: Tablet
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subject is between 18 and 55 years of age 2. Subject doesn't smoke more than 10 cigarettes, 2 cigars or 2 pipes per day 3. Subject has a quetelet index (BMI) of 18-30 kg/m2 4. Subject is able and willing to sign informed consent. 5. Subject is in good age-appropriate health condition 6. Subject had a normal blood pressure and pulse rate 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
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients 2. Positive HIV test 3. Positive hepatitis B or C test 4. Therapy with any drug (for two weeks prededing dosing) except for paracetamol 5. relevant history or presence of pulmonary disorders, cardiovascular, neurological, gastro-intestinal, renal and hepatic, hormonal, coagulation disorders. 6. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion 7. History or current abuse of drugs, alcohol or solvents 8. Inability to understand nature and extent of the trial and the procedures required 9. Participation in a drug trial within 60 days prior to the first dose 10. Donation of blood within 60 days prior to the first dose 11. Febrile illness within 3 days before the first dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of raltegravir on the pharmacokinetics of single-dose lamotrigine determined by intrasubject comparison.;Secondary Objective: To determine the effect of single-dose lamotrigine on the pahrmacokinetics of raltegravir when compared to historical controls. To evaluate the safety of combined use of single-dose lamotrigine and raltegravir.;Primary end point(s): - To determine the effect of raltegravir on the pharmacokinetics of single-dose lamotrigine determined by intrasubject comparison. - To determine the effect of single-dose lamotrigine on the pharmacokinetics of raltegravir when compared to historical controls. - To evaluate the safety of combined use of single-dose lamotrigine and raltegravir. | — |
Countries
Netherlands
Outcome results
None listed