Study AP-ADF-109
| Product: | Acurox® Tablets |
| Study: | AP-ADF-109 or Study 109 |
| Phase: | Phase I |
| Title: | A Multiple-Dose, Randomized, Open-Label, Two-Way Crossover Pharmacokinetic Study of Acurox (oxycodone HCl and niacin) Tablets, 5 mg/30 mg to Assess the Dose Proportionality of 5 mg and 10 mg Doses of Oxycodone HCl Administered Orally to Healthy Volunteers under Fasting Conditions |
Study Objective
To assess the mutliple dose linearity of Acurox Tablets
Design Summary
Study 109 is a multiple-dose, open-label, randomized, two-period crossover study in which 26 healthy subjects were scheduled to receive a dose every six hours for 84 hours (15 doses) with Acurox (oxycodone HCl and niacin) Tablets, 1 × 5 mg/30 mg in one study period and Acurox (oxycodone HCl and niacin) Tablets, 2 × 5 mg/30 mg in another study period.
Results Summary
Study 109 confirmed that Acurox Tablets demonstrates multiple dose linearity.