Healthy
Conditions
Brief summary
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)
Interventions
DRUGCarbamazepine
DRUGTipranavir
DRUGRitonavir
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 58 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h) | up to 12 hours after drug administration |
| Maximum measured concentration of Carbamazepine in plasma (Cmax) | up to 12 hours after drug administration |
| Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h) | up to 12 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Cmax | up to 12 hours |
| Cp12h | up to 12 hours after drug administration |
| Clearance (CL/F) | up to 12 hours after drug administration |
| Number of subjects with adverse events | up to 35 days |
| Time from dosing to the maximum concentration (Tmax) | up to 12 hours after drug administration |
| t1/2 (terminal elimination half-life) | up to 12 hours after drug administration |
| Volume of distribution | up to 12 hours after drug administration |
| Number of subjects with clinically relevant changes in laboratory parameters | up to 35 days |
| AUC0-12h | up to 12 hours after drug administration |
Outcome results
None listed