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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment sequence 1

Test - Reference - Reference - Test

Group Type EXPERIMENTAL

BI 201335 NA 120 mg capsule

Intervention Type DRUG

1 capsule of BI 201335 NA 120 mg capsule

BI 201335 NA 40 mg capsule

Intervention Type DRUG

3 capsules of BI 201335 NA 40 mg capsule

Treatment sequence 2

Reference - Test - Test - Reference

Group Type EXPERIMENTAL

BI 201335 NA 120 mg capsule

Intervention Type DRUG

1capsule of BI 201335 NA 120 mg capsule

BI 201335 NA 40 mg capsule

Intervention Type DRUG

3 capsules of BI 201335 NA 40 mg capsule

Interventions

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BI 201335 NA 120 mg capsule

1capsule of BI 201335 NA 120 mg capsule

Intervention Type DRUG

BI 201335 NA 120 mg capsule

1 capsule of BI 201335 NA 120 mg capsule

Intervention Type DRUG

BI 201335 NA 40 mg capsule

3 capsules of BI 201335 NA 40 mg capsule

Intervention Type DRUG

BI 201335 NA 40 mg capsule

3 capsules of BI 201335 NA 40 mg capsule

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes