Bioequivalence Study of Crushed Elbasvir/Grazoprevir Compared to the Whole Tablet

Exclusion Criteria

• •Creatinine clearance below 60 mL/min.
• •Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
• •Positive hepatitis B or C test
• •Pregnant female (as confirmed by an hCG test performed less than 4 weeks before day 1) or breast-feeding female. Female subjects of childbearing potential without adequate contra-ception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the study.
• •Therapy with any drug (for two weeks preceding Day 1), except for acetaminophen (max 2 gram/day).
• •Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disorders, renal and hepatic disorders (clinically relevant increased ALAT/ASAT or hyperbilirubinemia), hormonal disorders (especially diabetes mellitus), coagulation disorders.
• •Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
• •History of or current abuse of drugs, alcohol or solvents (positive drugs of abuse test).
• •Inability to understand the nature and extent of the study and the procedures required.
• •Participation in a drug study within 60 days prior to Day 1.
• •Donation of blood within 60 days prior to Day 1.
• •Febrile illness within 3 days before Day 1.
• •Co-worker of Radboud university medical center.