Drug Drug Interaction of BI 201335 and Tenofovir

Inclusion criteria:

1. Healthy males and female subjects and according to medical history, including the
physical examination, vital signs (blood pressure, pulse rate), 12-lead
electrocardiogram and clinical laboratory tests; all with acceptable findings.

2. Age =18 to =55 years

3. Weighing at least 50 kg, and body mass index >=18.5 and BMI <=29.9 kg/m2 (Body Mass
Index).

4. Volunteers must not leave the research unit, during the entire length of the study
and must be willing to comply with the protocol and complete all study-related
activities.

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure, pulse rate and
electrocardiogram) deviating from normal and of clinical relevance, as assessed by
the investigator.

2. Active diseases of the gastrointestinal, hepatic, renal, respiratory, cardiovascular,
metabolic, musculoskeletal, immunologic, rheumatologic, hormonal, neurological
system, clinically relevant electrolyte disorders or bleeding disorders that require
current medical treatment.

3. Diseases of the central nervous system or psychiatric disorders.

4. History of photosensitivity or recurrent rash.

5. History of orthostatic hypotension, fainting spells or blackouts.

6. Chronic or clinically relevant acute infections.

7. History of allergy/hypersensitivity (including drug allergy) which is deemed
relevant.

8. Intake of drugs with a long half-life >24:00 hours within at least one month or less
than ten half lives of the respective drug before enrollment in the study (with the
exception of hormonal contraceptives).

9. Use of any drugs which might influence the results of the trial up to 7 days prior to
enrolment as nutraceuticals and herbal remedies that would interfere with either the
absorption, distribution or metabolism of BI 201335 NA, or that prolong the QT/QTc
interval.

10. Use of any investigational drug within 30 days prior to enrollment; or the planned
use of any investigational drug during the course of the current study.

11. Smoking (>10 cigarettes or >3 cigars or >3 pipes/day)

12. Inability to abstain from smoking more than 3 cigarettes/day during the period of
dosing with study medication.

13. Drug and alcohol abuse (>60g/day).

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

15. Excessive physical activities within one week prior to administration or during the
trial.

16. Any laboratory value outside the reference range that is of clinical relevance at
screening, according to the judgment of the investigator, and in consultation with
the clinical monitor.

17. Known elevated liver enzymes in past with any compound (experimental or marketed).

18. Concomitant administration of any food product known to alter P450 enzyme activity
such as grapefruit juice, Seville oranges, St. John's Wort.

19. Concomitant administration of oral contraceptives (subjects who stopped oral
contraceptives at least 7 days prior to Day 1 may be included.

20. Inadequate venous access.

21. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
QTcF, or QTcB interval >450 ms).

22. Infection with hepatitis B (HBV), or hepatitis C virus (HCV),

23. Positive test for HIV-1 or HIV-2. For women of child bearing potential (WOCBP)

24. Pregnancy or planning to become pregnant within 2 months of study completion

25. Positive pregnancy test at screening visit

26. No proof of sterilization, or not willing or unable to consistently use an acceptable
method of double barrier contraception including IUD, or diaphragm with spermicidal
cream/jelly and condoms for male partner, during and up to 3 months after
completion/termination of the trial.

27. Lactation period with active breastfeeding from time of screening to 30 days after
end of trial visit.

For male subjects

28. No proof of sterilization, or not willing or unable to consistently use an acceptable
method of double barrier contraception including a condom each time and female
partner of child bearing potential consistently uses oral birth control pills, or an
IUD, or a diaphragm with spermicidal cream/jelly). Male subjects must not father a
child from administration of the first dose and up to 3 months after the last dose of
study medication.