The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA) - GRANOLA study

Conditions: HIV infection
MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

Registration Number: EUCTR2007-005405-21-NL

Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

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

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