Duchesnay
QC - Blainville
BiotechnologyFocus: Small Molecules, Devices
Duchesnay is a life sciences company focused on Small Molecules, Devices.
Women's Health
Open Jobs
1
Products & Portfolio (3)
BONJESTA
doxylamine succinate and pyridoxine hydrochloride
Peak
ORAL · TABLET, EXTENDED RELEASE
12.1 Mechanism of Action The mechanism of action of BONJESTA is unknown. 12.3 Pharmacokinetics The pharmacokinetics of BONJESTA has been characterized in healthy non-pregnant adult women. Absorption In a single-dose, crossover clinical trial conducted in 48 healthy, premenopausal women under fasting conditions, one BONJESTA (20 mg doxylamine succinate and 20 mg pyridoxine) tablet was bioequivalent to two combination tablets of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride based on the exposure (AUC) and peak concentration (C max ) of doxylamine and baseline corrected pyridoxal 5′-phosphate. Mean ± SD plasma (whole blood for pyridoxal) pharmacokinetic (PK) parameters are summarized in Table 2. Table 2 – Mean ± SD Single-Dose Pharmacokinetics of BONJESTA in Healthy Premenopausal Adult Women BONJESTA Mean±SD AUC 0-t (ng•h/mL) AUC 0-inf (ng•h/mL) AUC 0-72 (ng•h/mL) C max (ng/mL) T max Median (range) (h) Doxylamine N=48 1367.0 ± 356.7 1425.8 ± 405.1 --- 92.3 ± 15.7 4.5 (2.5-5.5) Pyridoxine N=47 42.3 ± 14.7 42.5 ± 14.7 --- 47.1 ± 18.7 0.5 (0.5-4.7) Pyridoxal Baseline corrected values N=48 N=46 for AUC 0-inf 203.7 ± 51.7 233.6 ± 55.9 --- 58.9 ± 17.0 3.0 (0.8-5.0) Pyridoxal 5′-Phosphate N=48 --- --- 1076.2 ± 382.2 30.1 ± 9.2 9.0 (3.0-16.0) In a multiple-dose, crossover clinical trial conducted in 31 healthy, premenopausal women, one BONJESTA (20 mg doxylamine succinate and 20 mg pyridoxine) tablet given twice daily for 11 days was bioequivalent to one combination tablet of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride given three times daily (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime), based on the exposure (AUC) and peak concentration (Cmax) of doxylamine and baseline corrected pyridoxal 5′-phosphate. Mean ± SD plasma (whole blood for pyridoxal) PK parameters are summarized in Table 3. Table 3 – Mean ± SD Multiple-Dose (Day 11) Pharmacokinetic Parameters of BONJESTA (given twice daily) in Healthy Premenopausal Adult Women BONJESTA Mean±SD AUC 0-24 (ng•h/mL) AUC 0-12 (ng•h/mL) AUC 0-6 (ng•h/mL) C max (ng/mL) T max Median (range) (h) Doxylamine N=34 2879.4 ± 696.0 1573.2 ± 406.5 883.6 ± 228.5 173.6 ± 45.5 3.5 (1.0-20.0) Pyridoxine N=34 80.0 ± 22.7 46.3 ± 15.4 45.3 ± 16.3 48.2 ± 23.7 1.5 (0.3-16.5) Pyridoxal Baseline corrected values N=34 1511.3 ± 300.0 848.1 ± 183.6 647.2 ± 149.6 189.6 ± 48.3 3.0 (2.0-15.0) Pyridoxal 5′-Phosphate N=34 1742.3 ± 554.3 831.7 ± 274.5 426.2 ± 144.0 85.9 ± 26.2 15.0 (2.0-24.0) Food Effect In a single-dose, crossover clinical trial conducted in 23 healthy, premenopausal women, the administration of a high fat, high calorie meal delayed the absorption of doxylamine, pyridoxine, and pyridoxine metabolites. This delay is associated with lower peak concentrations of doxylamine, pyridoxine, and pyridoxal. The extent of absorption for pyridoxine was decreased. The effect of food on the peak concentration and the extent of absorption of the pyridoxine component is more c
nauseavomiting of pregnancy in women
2016
0
DICLEGIS
doxylamine succinate and pyridoxine hydrochloride
Peak
ORAL · TABLET, DELAYED RELEASE
delayed-release tablets is unknown.
nauseavomiting of pregnancy in women
2013
30
OSPHENA
ospemifene
LOE Approaching
ORAL · TABLET
Selective Estrogen Receptor Modulators
2013
15
Open Jobs (1)
Interview Prep Quick Facts
Portfolio: 3 approved products
Top TAs: Women's Health
Open Roles: 1 active job
Portfolio Health
Peak2 (67%)
LOE Approaching1 (33%)
3 total products