Females who were lactating or who had a positive pregnancy test were also ineligible. Study Drug and Administration BCQB nasal sprays used in these studies were manufactured by Beijing Shiqiao Biological

and Pharmaceutical Co. Ltd (Beijing, China). The intranasal formulation provided different doses (22.5, 45, 60, 75, 90, 135, 180, and 225 μg) of BCQB in a 0.09 mL spray from a single-dose metered sprayer. The same metered sprayer (0.09 mL/spray) with different drug loads was used in tolerability and pharmacokinetic studies. buy BAY 73-4506 For intranasal administration, each subject received a single spray in each nostril, for a total of two sprays. For example, the dosage of 45 μg was provided by a spray of 22.5 μg/spray in each nostril (22.5 μg/spray × 2). Prior to the administration of BCQB, the subject gently blew

his or her nose. A physician administered the nasal spray and attempted to concentrate www.selleckchem.com/products/pci-32765.html the application on the lateral nasal wall, particularly along the inferior and middle turbinate mucosa, according to the standard operating procedures (SOPs). Study Design Single-Dose Escalation Tolerability Study An open-label, single-dose escalation

design was used to evaluate the safety and tolerability Bcl-w of BCQB after intranasal dosing (see table II). Subjects, 50% male and 50% female, were subsequently enrolled into the 45, 90, 180, 270, 360, and 450 μg dose groups (6–8 subjects in each group). The trial was designed to begin with the 45 μg dose group and would not proceed to the higher dose group until the safety and tolerability of the lower dose group was confirmed. Table II Study design Multiple-Dose Escalation Tolerability Study An open-label, multiple-dose escalation design was performed to begin with the 120 μg dose group (360 μg/day) according to the results of the single-dose tolerability study and would not proceed to the higher dose group (450 μg/day) until the safety and tolerability of the 360 μg dose group was confirmed (see table II). Subjects, 50% male and 50% female, were also subsequently enrolled into two dose groups (eight subjects in each), and were given 120 μg (360 μg/day) or 150 μg (450 μg/day) of BCQB via nasal spray three times daily (at 7.30am, 12:00pm and 7:00pm) for 14 days to assess its safety and tolerability.