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a dose of the hydrocodone bitartrate administered as either two 30-mg or one 60-mg · 1 trial · 1 indication
To assess the bioequivalence between 30-mg tablets and one 60-mg tablet of the hydrocodone bitartrate extended-release tablet.
To assess bioequivalence between two 30-mg tablets and one 60-mg tablet of the hydrocodone bitartrate extended-release tablet.
| Arm | Type | Description |
|---|---|---|
| Treatment Group AB | EXPERIMENTAL | Subjects in this group will receive study drug in the following sequence: * Treatment A: two 30-mg hydrocodone bitartrate extended-release tablets (reference) * Treatment B: one 60-mg hydrocodone bitartrate extended-release tablet (test). |
| Treatment Group BA | EXPERIMENTAL | Subjects in this group will receive study drug in the following sequence: * Treatment B: one 60-mg hydrocodone bitartrate extended-release tablet (test). * Treatment A: two 30-mg hydrocodone bitartrate extended-release tablets (reference). |
| Name | Type | Description |
|---|---|---|
| a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B). | DRUG | Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period. |
Inclusion Criteria: * Written informed consent is obtained. * The subject can read, speak, and write in English. * The subject is a man or woman 18 through 45 years of age, with a body mass index (BMI) of 20.0 to 30.0 kg/m2, inclusive. * The subject is in good health as determined by medical and ps...
The hydrocodone bitartrate extended-release tablet is being developed for the treatment of pain. Teva Pharmaceutical Industries Limited studied a 60 mg dose given as either two 30 mg tablets or one 60 mg tablet in a Phase 1 bioequivalence trial in the United States.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of the hydrocodone bitartrate extended-release tablet. The company sponsored the clinical study of the 60 mg dose administered as two 30 mg tablets or one 60 mg tablet.
The hydrocodone bitartrate extended-release tablet is in Phase 1 development. The single recorded trial, NCT01758978, was a Phase 1 study, and it has been completed. The drug remains investigational and is not approved for marketing.
Trial NCT01758978 was a crossover study assessing the bioequivalence of the hydrocodone bitartrate extended-release tablet. It enrolled 54 healthy adult volunteers aged 18 years and older in the United States, used a controlled design, and has been completed.