HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Sign In to gain access to subscriptions and/or personal tools.

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via HighWire Citing Articles via Web of Science (3) Citing Articles via Google Scholar Google Scholar Articles by Roy, P. Articles by Kapil, R. Search for Related Content PubMed PubMed Citation Articles by Roy, P. Articles by Kapil, R. Social Bookmarking                         What's this?

Effect of Multiple-Dose Dexloxiglumide on the Pharmacokinetics of Oral Contraceptives in Healthy Women

From the Department of Clinical Pharmacology and Drug Dynamics, Forest Research Institute, Jersey City, New Jersey (Dr Roy, Dr Jakate, Ms Patel, Dr Abramowitz, Dr Kapil); Department of Bioanalytical and Drug Metabolism, Forest Research Institute, Farmingdale, New York (Dr Wangsa); and Rotta Research Laboratorium S.p.A., Monza, Italy (Dr Persiani).

This study was undertaken to evaluate the effect of dexloxiglumide, a selective cholecystokinin receptor antagonist, on the pharmacokinetics of a combination oral contraceptive (OC). A single-blind, placebo-controlled, 2-period crossover study was conducted in 24 healthy young female subjects who received Ortho Tri-Cyclen containing ethinyl estradiol (EE, 0.035 mg) and norgestimate (NE, 0.180 mg/0.215 mg/0.250 mg per 7-day phase, respectively) for 5 days (days 17-21) concurrently with either 200 mg dexloxiglumide (3 times a day on days 17-20, followed by a single dose on day 21) or matching placebo during 2 consecutive 28-day OC dosing cycles. Plasma was sampled up to 24 hours for the determination of EE, NE, and 17-deactyl norgestimate (17-DNE, a rapidly formed pharmacologically active metabolite of NE). The geometric mean ratios (GMRs, dexloxiglumide/placebo) of the plasma concentration-time curve over 24 hours with corresponding 90% confidence intervals (CIs) for EE and 17-DNE were 1.21 (1.17-1.26) and 0.92 (0.89-0.95), respectively. The GMRs (90% CI) of C_max for EE and 17-DNE were 1.15 (1.09-1.20) and 0.93 (0.90-0.96), respectively. Coadministration of OC and dexloxiglumide was well tolerated and safe. Comparable systemic exposure of EE and 17-DNE in the presence and absence of dexloxiglumide suggests that dexloxiglumide treatment is unlikely to interfere with the safety and efficacy of oral contraceptives based on the analysis of the resulting pharmacokinetic profile.

Key Words: Dexloxiglumide • pharmacokinetics • oral contraceptives • drug interactions

Address for reprints: Ram Kapil, PhD, Forest Research Institute, Harborside Financial Center, Plaza V, Jersey City, NJ 07311.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. Boffito, D. Maitland, and A. Pozniak Practical Perspectives on the Use of Tipranavir in Combination With Other Medications: Lessons Learned From Pharmacokinetic Studies J. Clin. Pharmacol., February 1, 2006; 46(2): 130 - 139. [Abstract] [Full Text] [PDF]