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Also known as Hydrocodone bitartrate extended-release tablet
Hydrocodone bitartrate · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 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) |
| Normal Hepatic Function | EXPERIMENTAL | Intervention Drug: Hydrocodone bitartrate extended-release tablet |
| Moderate Hepatic Impairment | EXPERIMENTAL | Intervention Drug: Hydrocodone bitartrate extended-release tablet |
| Name | Type | Description |
|---|---|---|
| Hydrocodone Bitartrate extended-release tablet | DRUG | Hydrocodone bitartrate extended-release oral tablet will be administered at a dose of 45 mg and dosed one time on Day 1. Subjects will also be dosed with naltrexone hydrochloride to block opioid effects. |
Key Inclusion Criteria: All subjects: * Written informed consent is obtained. * The subject is a man or woman at least 18 years of age, with a body mass index (BMI) of 20 kg/m2 or more. * Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, be using a medica...
Hydrocodone bitartrate is a small molecule opioid agonist developed by Teva Pharmaceutical Industries Limited as an extended-release tablet. It is being studied in Phase 1 clinical development for use in patients with hepatic impairment or renal impairment, with the goal of characterizing how the drug behaves in these populations.
Hydrocodone bitartrate targets the opioid receptors OPRK1 (kappa), OPRD1 (delta), and OPRM1 (mu) as an agonist. By binding and activating these receptors, it modulates pain signaling pathways. This mechanism underlies its development as an extended-release opioid formulation.
Hydrocodone bitartrate is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is responsible for the extended-release tablet formulation and the clinical studies evaluating its pharmacokinetics in patients with hepatic or renal impairment.
Hydrocodone bitartrate is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program consists of completed pharmacokinetic studies in subjects with normal and impaired hepatic or renal function.
Hydrocodone bitartrate has been evaluated in two completed Phase 1 trials: NCT01319279, which studied pharmacokinetics in subjects with normal hepatic function and moderate hepatic impairment, and NCT01319266, which assessed pharmacokinetics in subjects with normal renal function and varying degrees of renal impairment. Both trials were conducted in the United States.
Yes, hydrocodone bitartrate extended-release tablet is another name for hydrocodone bitartrate. The extended-release tablet is the specific formulation developed by Teva Pharmaceutical Industries Limited. Both names refer to the same investigational product studied in the Phase 1 trials.