Subjects and Methods Study Design This was a single-center, randomized, single-dose, laboratory-blinded, two-period, two-sequence, crossover study. A single oral dose of doxylamine hydrogen succinate 25 mg was administered
under either fed or fasting conditions in each study period. A 25 mg dose was used, since this is the recommended dosage regimen. No higher doses of the drug are currently recommended. Since the Physician’s Desk Reference rates doxylamine as being in pregnancy category B, it was acceptable to include women in the present study. To ensure that no carryover effect was observed, a wash-out period of seven calendar days was observed between drug administrations, corresponding to more than 10 times the expected half-life of the moiety to be measured. It should be noted that check details the randomization code was not made available to the personnel selleck screening library in charge of the determination of plasma drug concentrations (Algorithme Pharma Inc., Laval, QC, Canada) until the analytical tables
were finalized and audited by the quality assurance department. The protocol and the informed consent forms were approved by an independent review board (ETHIPRO) on June 17, 2010. All subjects voluntarily agreed to participate in this study and signed the informed consent form after having fully comprehended its contents and prior to initiation of the study procedures. This study was performed in compliance with Good Clinical Practice. Study Population Subject screening procedures included informed consent, an inclusion/exclusion check, demography, medical history, medication history, physical examination, height, weight, body mass index, and a concomitant medication check. Subjects were in good health as determined by the medical history, physical examination (including vital signs), 12-lead electrocardiogram, and the usual clinical laboratory tests (hematology, biochemistry, urinalysis), including negative HIV, hepatitis
B, and hepatitis C tests, negative screening for ethanol and drugs of abuse in urine, and a negative pregnancy test (for female subjects). All participating subjects were judged to be eligible for the study when Immune system assessed against the inclusion and exclusion criteria. Tolerability was evaluated through assessment of adverse events (AEs), standard laboratory evaluations, and vital signs. The predetermined reason for excluding subjects from the study was for any safety issues as determined by the investigator. Also, subjects could be withdrawn because of protocol violations, administrative problems, difficulties in blood collection, occurrence of emesis during the time interval described in the protocol, or other reasons described in the protocol. Furthermore, subjects were allowed to discontinue their participation in the study at any time.