7 results
Primary objective1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulationSecondary objective1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed…
Section 7 of the protocol:7. TRIAL OBJECTIVES AND PURPOSE* To assess the long term bronchodilator efficacy of Aclidinium bromide/Formoterol fumarate, administered twice a day, compared to Salmeterol/Fluticasone propionate (SeretideTM AccuhalerTM) in…
Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…
To investigate the differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone in increasing sexual satisfaction during sexual activity in the domestic setting in…
Primary(Part I and Part II):- To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) in the QW and/or Q3W regimens of RO7122290 in combination with cibisatamab after pretreatment with obinutuzumab- To characterize the…
Primary Objective:The primary objective is to demonstrate the efficacy of 1 or 2 dose regimens of HZN-825 versus placebo in subjects with diffuse cutaneous SSc, as determined by a comparison of change in forced vital capacity (FVC) % predicted after…
Core phase: The overall objective of the core phase is to investigate the efficacy, safety and tolerability of 2 dose regimens of HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1), administered once daily (QD) or twice…