Healthy
Conditions
Brief summary
Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV) administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the short-term safety of this combination
Interventions
DRUGTPV + RTV (low dose)
DRUGTPV + RTV (high dose)
DRUGddl
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subjects as determined by results of screening * Female subjects were not lactating and not of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone (FSH) with low estradiol and no estrogen supplementation). Females were to use barrier contraception (e.g. condoms) for at least one month prior to administration of study medication, during the study and at least one month after release from the study. Women were to have negative pregnancy tests * Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation * Age \>=18 and \<=60 years * Body mass index (BMI) \>=18.5 and \<=29.9 kg/m2
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B, Hepatitis C, or HIV infection * History of orthostatic hypotension, fainting spells and blackouts * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator including study drugs * Intake of drugs with a long half-life (\> 24 hours) or enzyme altering drug within 1 month prior to administration of study drugs * Use of any drugs that might have influenced the results of the trial within 10 days prior to administration or during the trial (in addition to specific medication prohibitions mentioned in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (AUC 0-12) Area under the plasma concentration time curve from 0-12 hours | up to 12 hours after dose administration |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 12 hours after dose administration |
| (C6h) drug concentration in plasma at 6 hours after drug administration | up to 6 hours after dose administration |
| (C12h) drug concentration in plasma at 12 hours after drug administration | up to 12 hours after dose administration |
| Cnh (plasma concentration n hours after drug administration) | up to 12 hours after dose administration |
Secondary
| Measure | Time frame |
|---|---|
| t½ (Terminal half-life of the analyte in plasma) | up to 12 hours after dose administration |
| Cmax,ss (maximum plasma concentration at steady state) | up to 12 hours after dose administration |
| Number of subjects with abnormal changes in laboratory parameters | up to 40 days |
| Number of subjects with adverse events | up to 40 days |
| MRT (mean residence time) | up to 12 hours after dose administration |
| Tmax (time to the maximum plasma concentration) | up to 12 hours after dose administration |
| CL/F (apparent oral clearance) | up to 12 hours after dose administration |
| Vz/F (apparent volume of distribution) | up to 12 hours after dose administration |
Outcome results
None listed