Status:
COMPLETED
Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
20-58 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02253849
Start Date
November 1 2005
Last Update
October 1 2014
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