If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ASHP: Randomised Study of Bioequivalence of Oxandrolone 10 mg Tablet Promises Pill Burden Relief By Maury M. Breecher, PhD, MPH SAN DIEGO, CA -- June 5, 2003 -- Reducing the pill burden of patients with involuntary weight-loss might be possible, says one of the authors of a study presented in a poster at the American Society of Health-System Pharmacists (ASHP) annual summer meeting held here May 31-June 4. HIV and cancer patients, among others, use oxandrolone -- available now as 2.5-mg tablet -- to combat involuntary weight loss. Karin A. Greenberg, PharmD, Director of Pharmacological Vigilance and Medical Information at Bio-Technology General Corp., in East Brunswick, New Jersey, and colleagues conducted an open label, randomised, single-centre, crossover study to compared the safety and bioequivalence of a test product -- a 10-mg, once-a-day oxandrolone tablet against four 2.5-mg tablets ingested as a single dose. "With a dose of 10 mg twice a day, using 2.5 mg tablets, that’s eight tablets a day, a high pill burden for patients who already take a lot of pills and who may have trouble swallowing," said Dr. Greenberg. A total of 36 healthy men completed both phases of the study. Each subject acted as his own control. Plasma samples were analysed for oxandrolone levels using liquid chromatography coupled to a triple quadruple mass spectrometer, methodology developed and validated at the University of California Los Angeles (UCLA) Olympic Analytical Laboratory. The drug concentration to time data were plotted for each subjects’ plasma samples for each of the two dosage schedules (one 10 mg. tablet versus four 2.5 mg. tablets given as one single dose). Two one-sided t-tests (0.05) were tested for various area-under-the-curve (AUC) variables and an analysis of variance (ANOVA) was performed on all pharmacokinetic (PK) parameters When the researchers plotted the mean drug concentrations from plasma samples, they found that the two formulations had nearly identical systemic availability. "The analysis derived from the PK parameters demonstrated no statistically significant difference between the two dosage forms," according to the poster. "The metabolic and elimination characteristics of the two formulations were very similar," said Dr. Greenberg. "There were no unexpected adverse events or abnormal laboratory findings." "The results for all PK variables indicated that bioequivalence was achieved between one 10 mg tablet and four oxandrolone 2.5 mg tablets when given as a single dose," concluded the authors. Dr. Greenberg summed up by saying, "The bottom line of this study is reducing the pill burden with a 10 mg tablet. Patients would get two tablets a day instead of eight when they are being treated at the 20 mg daily dose."
[Study title: Randomized Single Dose Study of Bioequivanence of Oxsandrolone 10 mg Tablets Compared to Oxandrolone 2.5 Tablets.]
|
