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Study to characterize the effects of two dose combinations of Tipranavir (TPV)/Ritonavir (RTV) (TPV 750 mg/RTV 200 mg and TPV 500 mg/RTV 100 mg), administered twice-daily, on the pharmacokinetics of Norethindrone-Ethinyl Estradiol (NET/EE) 1 mg/ 0.035 mg administered as a single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPV/RTV low dose | Experimental |
| |
| TPV/RTV high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tipranavir low dose | Drug |
| ||
| Tipranavir high dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration time curve | up to day 17 | |
| Maximum plasma concentration of the analyte | up to day 17 | |
| Drug concentration of the analyte in plasma at 12 hours after administration | up to day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Oral clearance of the analyte | up to day 17 | |
| Time of maximum concentration of the analyte | up to day 17 | |
| Apparent terminal half life of the analyte |
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Inclusion Criteria:
Exclusion Criteria:
Female subjects who are of reproductive potential who:
Participation in another trial with an investigational medicine within 30 days prior to Day 0 (Visit 2)
Use of any medication listed in the protocol within 30 days prior to Day 0 (Visit 2)
Use of any other pharmacological contraceptive (including oral, patch or injectable contraceptives) for 1 month prior to study initiation and for the duration of the study
Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial
History of central nervous system (CNS), gastrointestinal, hepatic, or renal disorders within the past sixty (60) days. Subjects will be excluded for these disorders greater than sixty days if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
History of thrombotic disease
History of migraine headache
Have serological evidence of hepatitis B or C virus
Have serological evidence of exposure to HIV
Recent history of alcohol or substance abuse (within 6 months of study period)
Cigarette smoking (greater than 10 cigarettes per day)
Blood or plasma donations within 30 days prior to Day 0 (Visit 2) or during the trial.
Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/min or >90 beats/min. For subjects with a resting heart rate below 50, due to a high fitness level, the investigator may discuss exclusion with the medical monitor on a case-by-case basis
Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering Tipranavir, Ritonavir or NET/EE to the subject
Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2)
Subjects who are currently taking any over-the-counter drug within 7 days prior to Day 0,(Visit 2) or who are currently taking any prescription drug that, in the opinion of the investigator in consultation with the clinical monitor, might interfere with either the absorption, distribution or metabolism of the test substances
Known hypersensitivity to TPV, RTV, or NET/EE
Inability to comply with the protocol
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|
| Ritonavir low dose | Drug |
|
|
| Ritonavir high dose | Drug |
|
|
| Norethindrone-Ethinyl Estradiol | Drug |
|
|
| up to day 17 |
| Number of subjects with adverse events | up to 45 days |
| Number of subject with clinically relevant changes in laboratory parameters | up to 17 days |
| ID | Term |
|---|---|
| C107201 | tipranavir |
| D019438 | Ritonavir |
| C484525 | ovcon 35 |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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