The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA)
- Conditions
- HIV infections1002146010047438
- Registration Number
- NL-OMON32367
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
- men in the age of 18- 55 years
- does not smoke more than 10 cigarettes, 2 cigars or 2 pipes
- has a Quetelet Index between 18 - 30 kg/m2
- willing and able to sign informed consent
- in a good health age-appropriate
- heeft een normale bloeddruk en pols
- sensitivity to medicinal products
- HIV positive
- hepatitis B or C positive
- therapy with any drug, except for paracetamol
- relevant history or presence of pulmonary disorders, cardiovascular disorders, neurological disorders, gastro-intestinal disorders, renal- or hepatic disorders, hormonal disorders especially diabetes mellitus, coagulation disorders
- history or current abuse of drugs, alcohol or solvents.
- inability to understand the nature and extent of the trial and the procedures required
- participation in a drug trial within 60 days prior to the first dose
- donation of blood within 60 days prior to the first dose
- febrile illness within 3 days before the first dose
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the effect of raltegravir on the pharmacokinetics of single-dose<br /><br>lamotrigine determined by intrasubject comparison. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the effect of single-dose lamotrigine on the pharmacokinetics of<br /><br>raltegravir when compared to historical controls<br /><br>To evaluate the safety of combined use of single-dose lamotrigine and<br /><br>ralte-gravir</p><br>