Irena Nulman1, Gideon Koren. 1. The Motherisk Program, Division of Clinical Pharmacology & Toxicology, The Hospital for Sick Children, Toronto, Canada.
Abstract
BACKGROUND: The delayed-release combination of doxylamine succinate and pyridoxine hydrochloride was the most commonly used antiemetic (Bendectin) approved by FDA for nausea and vomiting of pregnancy (NVP) until its removal of the market in 1983. The drug is widely used today in Canada (Diclectin). The pharmacokinetics of Diclectin has never been described in humans. OBJECTIVES: To compare the pharmacokinetics of Diclectin to oral solutions of its two components. SUBJECTS AND METHODS: A randomized, cross over, open label design, comparing the pharmacokinetics of Diclectin to those of the oral solutions of the two components in 18 healthy adult, non pregnant women of childbearing age. RESULTS:Diclectin exhibited similar oral bioavailability to those of the oral solutions. In contrast, the time-to-peak, (Tmax), reflecting the rate of absorption, was 3-6 times longer for the two components of the delayed-release drug confirming its delayed-release characteristics. CONCLUSION: The pharmacokinetic profile of Diclectin well explains its documented delayed efficacy.
RCT Entities:
BACKGROUND: The delayed-release combination of doxylamine succinate and pyridoxine hydrochloride was the most commonly used antiemetic (Bendectin) approved by FDA for nausea and vomiting of pregnancy (NVP) until its removal of the market in 1983. The drug is widely used today in Canada (Diclectin). The pharmacokinetics of Diclectin has never been described in humans. OBJECTIVES: To compare the pharmacokinetics of Diclectin to oral solutions of its two components. SUBJECTS AND METHODS: A randomized, cross over, open label design, comparing the pharmacokinetics of Diclectin to those of the oral solutions of the two components in 18 healthy adult, non pregnant women of childbearing age. RESULTS:Diclectin exhibited similar oral bioavailability to those of the oral solutions. In contrast, the time-to-peak, (Tmax), reflecting the rate of absorption, was 3-6 times longer for the two components of the delayed-release drug confirming its delayed-release characteristics. CONCLUSION: The pharmacokinetic profile of Diclectin well explains its documented delayed efficacy.
Authors: Sebastián Videla; Mounia Lahjou; Pascal Guibord; Zhengguo Xu; Carles Tolrà; Gregorio Encina; Eric Sicard; Artur Sans Journal: Drugs R D Date: 2012-12-01
Authors: Gideon Koren; Shannon Clark; Gary D V Hankins; Steve N Caritis; Jason G Umans; Menachem Miodovnik; Donald R Mattison; Ilan Matok Journal: BMC Pregnancy Childbirth Date: 2015-03-18 Impact factor: 3.007
Authors: Gideon Koren; Shannon Clark; Gary D V Hankins; Steve N Caritis; Jason G Umans; Menachem Miodovnik; Donald R Mattison; Ilan Matok Journal: BMC Pregnancy Childbirth Date: 2016-11-24 Impact factor: 3.007
Authors: Sebastián Videla; Jesús Cebrecos; Mounia Lahjou; France Wagner; Pascal Guibord; Zhengguo Xu; Anna Cabot; Mercedes Encabo; Gregorio Encina; Eric Sicard; Artur Sans Journal: Drugs R D Date: 2013-06