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)
Minimum age: 20 Years.
Maximum age: 58 Years.
Gender(s): Both.
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