Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product [IMP]) and reference products that could impact the bioavailability of the medication when administered under fasting conditions.
Full description
The objective of the study is to compare the bioavailability of doxylamine between two oral delayed-release formulations containing the fixed-dose combination of doxylamine succinate 10 milligrams (mg)/pyridoxine hydrochloride 10 mg
after an administration of a single dose equivalent to doxylamine succinate 20 mg and pyridoxine hydrochloride 20 mg (i.e., 2 tablets) under fasting conditions to determine bioequivalence in terms of rate and extent of absorption.
Furthermore, the tolerability of the fixed-dose combination doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg will be evaluated in healthy women in a dose equivalent to doxylamine succinate 20 mg and pyridoxine hydrochloride 20 mg.
Sex
Ages
Volunteers
Inclusion criteria
Participation will be voluntary and according to the guidelines proposed by the Health General Law and informed consent will be obtained according to the previously mentioned law. In addition, the study will be conducted according to the ethical principles that have their origin in the Declaration of Helsinki, the review of Brazilian laws, and Good Clinical Practice.
Only healthy female participants aged between 18 and 55 years will be included.
The body mass index must be between 18.0 and 27.0 kilograms per square meter according to the Quetelet index.
Participants must be willing to use contraceptive methods (including barrier methods, non-hormonal intra-uterine device, or have a preexistent bilateral tubal ligation) during the conduct of the study and for up to 3 weeks after the last dose is administered.
Participants must be healthy as determined by the results of a complete clinical history recorded by the clinical investigational site physicians and the results of the laboratory examinations and 12-lead electrocardiogram done by a certified clinical laboratory.
The allowed limits of variation within normal in the screening visit will be: systolic blood pressure (sitting) less or equal to 120 mmHg, diastolic blood pressure less or equal to 80 mm Hg, heart rate between 50 and 100 beats per minute and respiratory rate between 14 and 20 breaths per minute according to the current standard operating procedure. Vital signs will be measured after 10 minutes of resting in a sitting position.
Laboratory and other examinations to be conducted for the inclusion of participants will be:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal