Bioavailability of Tipranavir/Ritonavir Paediatric Solution Compared to Tipranavir/Ritonavir Capsules in Healthy Female and Male Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tipranavir oral solution; Drug: Ritonavir soft gel capsules; Drug: Tipranavir capsules; Other: High fat breakfast; Drug: Ritonavir oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02251158

1182.45

Details and patient eligibility

About

Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r) oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food versus without food.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males and females according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests

   • No finding deviating from normal and of clinical relevance
   • No evidence of a clinically relevant concomitant disease

2. Age ≥ 18 and Age ≤ 55 years

3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)

4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion criteria

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

2. Surgery of gastrointestinal tract (except appendectomy)

3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

4. History of relevant orthostatic hypotension, fainting spells or blackouts

5. Chronic or relevant acute infections

6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator

7. Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial

8. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial (e.g. drugs which contain polyethylene glycol or vitamin E)

9. Participation in another trial with an investigational drug within two months prior to administration or during the trial

10. Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)

11. Inability to refrain from smoking on trial days

12. Alcohol abuse (more than 60 g/day)

13. Drug abuse

14. Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)

15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

16. History of any bleeding disorder or acute blood coagulation defect of vitamin K deficiency caused by anticoagulation therapy or malabsorption

17. Vitamin E supplement intake

18. Excessive physical activities (within one week prior to administration or during the trial)

19. Any laboratory value outside the reference range that is of clinical relevance

20. Inability to comply with dietary regimen of study centre

    For female subjects:

21. Pregnancy

22. Positive pregnancy test

23. No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device

24. Inability to maintain this adequate contraception during the whole study period

25. Lactation period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

TPV/r with food

Experimental group

Description:

Tipranavir/Ritonavir paediatric/oral solution

Treatment:

Drug: Tipranavir oral solution

Other: High fat breakfast

Drug: Ritonavir oral solution

TPV/r

Experimental group

Description:

Tipranavir/Ritonavir paediatric/oral solution

Treatment:

Drug: Tipranavir oral solution

Drug: Ritonavir oral solution

TPV/r capsules

Active Comparator group

Treatment:

Drug: Ritonavir soft gel capsules

Drug: Tipranavir capsules