scholarly journals A randomized two way cross over study for comparison of absorption of vitamin D3 buccal spray and soft gelatin capsule formulation in healthy subjects and in patients with intestinal malabsorption

2015 ◽  
Vol 14 (1) ◽  
Author(s):  
MC Satia ◽  
AG Mukim ◽  
KD Tibrewala ◽  
MS Bhavsar
2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3081-3081 ◽  
Author(s):  
Azra Raza ◽  
Rami S. Komrokji ◽  
Roserika Brooks ◽  
Jeffrey E. Lancet ◽  
Alan F. List ◽  
...  

3081 Background: Rigosertib (ON 01910.Na) is a novel multikinase inhibitor, with selective cytotoxic effects on tumor cells without impact on normal cells. Rigosertib, administered as a 3-day continuous infusion, is now undergoing phase 3 evaluation in higher risk MDS patients refractory to hypomethylating agents. Here, we report the results of the effect of food on the absolute bioavailability of a novel rigosertib oral formulation (soft gelatin capsule) in MDS patients. Methods: This was a single-dose, three-treatment, three-period sequential design for studying the effects of food on the bioavailability of an immediate-release soft gelatin capsule formulation. The following dosing groups were tested in 12 patients: IV Dose 800 mg/m2 over 24 hours and oral dose 560 mg (2 x 280 mg capsules) under fasting and fed conditions. The oral dose was the recommended phase 2 dose, as reported previously (R.S. Komrokji et al., Oral Formulation of Rigosertib (ON 01910.Na) in Patients with Myelodysplastic Syndrome (MDS) – Phase I Study Results. Blood 2011, 118:Abstract #3797). Plasma samples were collected pre-dose, and over 32 hours (IV dose) or 8 hours (oral dose) after dose initiation. Rigosertib plasma levels were analyzed by a validated LC/MS/MS method. Pharmacokinetic parameters were estimated by noncompartmental analysis (WinNonlinÒ). Results: Rigosertib pharmacokinetic parameters are presented in the table below. The results of the present study demonstrate good oral bioavailability under fasting condition.Oral administration of rigosertib after a meal decreased Cmax and AUC by 77% and 61%, respectively, compared to fasting conditions. Conclusions: The results of this study support the potential for oral delivery of rigosertib, which could become a preferred therapy over a 3-day continuous intravenous infusion. [Table: see text]


Author(s):  
Liliana Cațan ◽  
Simona Cerbu ◽  
Elena Amaricai ◽  
Oana Suciu ◽  
Delia Ioana Horhat ◽  
...  

(1) Background: Adolescent idiopathic scoliosis (AIS) can be associated with vitamin D deficiency and osteopenia. Plantar pressure and stabilometry offer important information about posture. The objectives of our study were to compare static plantar pressure and stabilometric parameters, serum 25-OH-vitamin D3 and calcium levels, and bone mineral densitometry expressed as z-score in patients with moderate AIS and healthy subjects. (2) Methods: 32 female adolescents (idiopathic S shaped moderate scoliosis, main lumbar curve) and 32 gender and age-matched controls performed: static plantar pressure, stabilometry, serum 25-OH-vitamin D3 and calcium levels, and dual X-ray absorptiometry scans of the spine. (3) Results: In scoliosis patients, significant differences were recorded between right and left foot for total foot, first and fifth metatarsal, and heel loadings. Stabilometry showed a poorer postural control when compared to healthy subjects (p < 0.001). Patients had significantly lower vitamin D, calcium levels, and z-scores. Lumbar Cobb angle was significantly correlated with the z-score (r = −0.39, p = 0.02), with right foot fifth metatarsal load (r = −0.35, p = 0.04), center of pressure CoPx (r = −0.42, p = 0.01), CoP displacement (r = 0.35, p = 0.04) and 90% confidence ellipse area (r = −0.38, p = 0.03). (4) Conclusions: In our study including female adolescents with idiopathic S shaped moderate scoliosis, plantar pressure and stabilometric parameters were influenced by the main scoliotic curve.


2006 ◽  
Vol 8 (2) ◽  
pp. 36
Author(s):  
Montaner SG Julio ◽  
Malte Schutz ◽  
Robert Schwartz ◽  
Dushyantha T Jayaweera ◽  
Alfred F Burnside ◽  
...  

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