Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers

Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg twice daily, depending on tolerability, and administered alone and in combination with tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg twice-daily)


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and non-pregnant, non-lactating female subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
* Age \>19 and \<59 years
* Weight ≥ 60 kg
* BMI \>18.5 and \<35 kg/m2
* Ability to maintain adequate contraception if applicable

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* AV block including 1°
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Relevant history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Known hypersensitivity to TPV, Ritonavir (RTV), carbamazepine or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
* Known elevated liver enzymes in past trials with any compound
* Intake of drugs with a long half-life (\>24 hours) (\<1 month prior to administration or during the trial)
* Prescription or over the counter medications (including vitamins, minerals, herbal supplements and antacids), dietary supplements 14 days prior to study drug administration or expected during the trial)
* Participation in another trial with an investigational drug (\<2 months prior to administration or expected during trial)
* Smoker with a consumption of \>10 cigarettes or \>3 cigars or \>3 pipes/day and those who cannot keep tobacco intake constant
* Alcohol abuse (\>60 g/day)
* Drug abuse
* Blood donation or loss \>400 mL, \<1 month prior to administration or expected during the trial
* Clinically relevant laboratory abnormalities
* Inability to comply with dietary regimen of study centre

For female subjects:

* Pregnancy or planning to become pregnant within 60 days of study completion
* Positive pregnancy test
* Have not been using a barrier method of contraception for at least 3 months prior to participation in the study
* Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
* Chronic use of oral contraception or hormone replacement containing ethinyl estradiol
* Breast-feeding