Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: BI 201335 NA 120 mg capsule; Drug: BI 201335 NA 40 mg capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01704846

1220.53

Details and patient eligibility

About

The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Enrollment: 60 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male volunteers without any clinical significant findings and complications
2. Age: 20 - 45 years
3. BMI: 18.5 - 25.0 kg/m2
4. Signed informed consent

Exclusion criteria

1. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
2. Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
4. History of jaundice
5. Surgery of the gastrointestinal tract (except appendectomy).
6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
7. History of relevant orthostatic hypotension, fainting spells or blackouts.
8. Chronic or relevant acute infections.
9. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
10. 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
11. Use of drugs which might reasonably influence the results (pharmacokinetic) of the trial within at least 10 days prior to administration or during the trial.
12. Participation in another trial with an investigational drug within two months prior to administration or during the trial.
13. Smoking (>10 cigarettes or >3 cigars or >3 pipes/day).
14. Inability to refrain from smoking during the trial.
15. Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake).
16. Drug abuse.
17. Blood donation (more than 100 mL within four weeks prior to administration).
18. Excessive physical activities (within one week prior to administration).
19. Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement.
20. Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Treatment sequence 1

Experimental group

Description:

Test - Reference - Reference - Test

Treatment:

Drug: BI 201335 NA 40 mg capsule

Drug: BI 201335 NA 40 mg capsule

Drug: BI 201335 NA 120 mg capsule

Drug: BI 201335 NA 120 mg capsule

Treatment sequence 2

Experimental group

Description:

Reference - Test - Test - Reference

Treatment:

Drug: BI 201335 NA 40 mg capsule

Drug: BI 201335 NA 40 mg capsule

Drug: BI 201335 NA 120 mg capsule

Drug: BI 201335 NA 120 mg capsule