Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment

Exclusion Criteria

• •Subjects were not be eligible for the study if they meet any of the following criteria:
• •1. Women who were pregnant or breastfeeding.
• •2. Any clinically significant condition that would, in the opinion of the Investigator, preclude study participation.
• •3. Uncontrolled blood pressure, i.e., subjects has a sitting systolic blood pressure \>180 mmHg or \<90 mmHg, and/or a sitting diastolic blood pressure \>120 mmHg or \<50 mmHg at screening.
• •4. A Body mass Index (BMI) \>40 kg/m2.
• •5. A known allergy or hypersensitivity to hydrocodone, or other opioids.
• •6. Have taken any investigational drug within 30 days prior to the Day 1 visit or be currently enrolled in another investigational drug study.
• •7. Have used a monoamine oxidase inhibitor within 14 days prior to the Day 1 visit.
• •8. Were taking opioids during the 30 days prior to Day 1 or needing to take opioids during the study period.
• •9. Positive for HIV. Healthy control subjects must have not been Hepatitis C Virus (HCV) positive, renal-impaired subjects can be HCV positive but should not be receiving treatment.
• •10. A history of any illicit substance abuse in the past 2 years or any history of opioids abuse. Subjects should not have been current abusers of alcohol and must have a negative serum alcohol at Screening and Day-1.
• •11. Had a positive quantitative urine drug screen for illicit drugs, or non-prescribed controlled substances at screening.
• •12. Had made a plasma donation within 7 days prior to Day 1.
• •13. Had made any significant donation or loss of blood within 56 days prior to Day 1.
• •14. Had taken CYP2D6 and/or 3A4 inhibitors within 7 days prior to Day 1 and/or CYP2D6 and/or 3A4 inducers within 21 days prior to Day 1.