Title |
Comparison of single-dose and multiple-dose pharmacokinetics between two formulations of hydrocodone bitartrate/acetaminophen: immediate-release versus biphasic immediate- release/extended release
|
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Published in |
Journal of Pain Research, September 2015
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DOI | 10.2147/jpr.s79578 |
Pubmed ID | |
Authors |
Krishna Devarakonda, Kenneth Kostenbader, Michael J Giuliani, Jim L Young |
Abstract |
This study aimed to compare the single-dose and steady-state pharmacokinetics (PK) of biphasic immediate-release (IR)/extended-release (ER) hydrocodone bitartrate (HB)/acetaminophen (APAP) and IR HB/APAP. The study was conducted in a contract research center. The study included healthy adults. In a three-way crossover study, Study 1, participants received the following treatments: (A1) a single dose of IR/ER HB/APAP 7.5/325 mg one tablet, followed by one tablet every 12 hours (q12h); (B1) a single dose of IR/ER HB/APAP 7.5/325 mg two tablets, followed by two tablets q12h; (C1) a single dose of IR HB/APAP 7.5/325 mg two tablets (one tablet at hours 0 and 6), followed by one tablet q6h. In a two-way crossover study, Study 2, participants received the following treatments: (A2) an initial dose of IR/ER HB/APAP 7.5/325 mg three tablets, followed by two tablets q12h; (B2) three doses of IR HB/APAP 7.5/325 mg one tablet q4h, followed by one tablet q6h. PK values were compared, and adverse events were assessed. Single-dose and steady-state area under the concentration-time curves for hydrocodone and APAP were similar for IR/ER and IR HB/APAP; the steady-state peak plasma concentrations (C max) at steady state were also similar, but single-dose C max for hydrocodone was lower for IR/ER HB/APAP. For most PK parameters, 90% confidence intervals for geometric least squares mean ratios were not meaningfully different (80%-125%). Steady state was achieved in 2-3 days for IR/ER HB/APAP and in 2 days for IR HB/APAP. Median time to C max was longer for IR/ER HB/APAP versus IR HB/APAP (P,0.05). Adverse events were similar across treatments. PK outcomes and tolerability were similar for IR/ER HB/APAP and IR HB/APAP. |
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Geographical breakdown
Country | Count | As % |
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United States | 1 | 11% |
Italy | 1 | 11% |
Unknown | 7 | 78% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Lecturer | 1 | 11% |
Student > Bachelor | 1 | 11% |
Student > Ph. D. Student | 1 | 11% |
Researcher | 1 | 11% |
Professor > Associate Professor | 1 | 11% |
Other | 1 | 11% |
Unknown | 3 | 33% |
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---|---|---|
Medicine and Dentistry | 2 | 22% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 11% |
Agricultural and Biological Sciences | 1 | 11% |
Nursing and Health Professions | 1 | 11% |
Unknown | 4 | 44% |