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Also known as Hydrocodone bitartrate extended-release tablet, Hydrocodone Bitartrate extended-release tablet
Hydrocodone bitartrate · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Normal Hepatic Function | EXPERIMENTAL | Intervention Drug: Hydrocodone bitartrate extended-release tablet |
| Moderate Hepatic Impairment | EXPERIMENTAL | Intervention Drug: Hydrocodone bitartrate extended-release tablet |
| Normal Renal Function | EXPERIMENTAL | Subjects with normal renal function |
| Mild Renal Impairment | EXPERIMENTAL | Subjects with mild renal impairment (defined by an estimated creatinine clearance of \> 50 and up to 80 mL/min) |
| Moderate Renal Impairment | EXPERIMENTAL | Subjects with moderate renal impairment (defined by an estimated creatinine clearance of 30-50 mL/min) |
| Severe Renal Impairment | EXPERIMENTAL | Subjects with severe renal impairment (defined by an estimated creatinine clearance of less than 30 mL/min) |
| End Stage Renal Disease (ESRD) | EXPERIMENTAL | Subjects with ESRD (defined as being on hemodialysis for at least 6 months prior to enrollment and be receiving standard in-center dialysis treatments three times a week) |
| Name | Type | Description |
|---|---|---|
| Hydrocodone bitartrate extended-release tablet | DRUG | 15 mg (single dose) |
Inclusion Criteria: 1. All subjects: * Written informed consent is obtained 2. Subjects with normal hepatic function: * The subject is in generally good health (age-appropriate) as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, coagula...