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Trial to study the pharmacokinetics and food effect of solid and liquid formulations of TMC435 versus the reference

Update Il y a 5 ans
Reference: EUCTR2011-005808-14

Woman and Man

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Extract

• To compare the rate and extent of absorption of TMC435 following administration of a single dose of 2 different liquid formulations to that following administration of a single dose of the Phase III 150 mg capsule, after a highfat breakfast in healthy adult subjects. • To compare the rate and extent of absorption of TMC435 following administration of a single dose of 2 different liquid formulations in the fed (high-fat) and fasted state in healthy adult subjects. • To compare the rate and extent of absorption of TMC435 following administration of a single dose of 2 different capsule concept formulations to that following administration of a single dose of the Phase III 150 mg capsule, after a high-fat breakfast in healthy adult subjects.

Inclusion criteria

  • Hepatitis C Virus (HCV) genotype-1 infection

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