NCT04564144 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Aljimaee YH, El-Helw AR, Ahmed OA, El-Say KM
Development and optimization of carvedilol orodispersible tablets: enhancement of pharmacokinetic parameters in rabbits. Drug Des Devel Ther. 2015 Mar 5;9:1379-92. doi: 10.2147/DDDT.S80294. eCollection 2015.
Leach WT, Simpson DT, Val TN, Yu Z, Lim KT, Park EJ, Williams RO 3rd, Johnston KP
Encapsulation of protein nanoparticles into uniform-sized microspheres formed in a spinning oil film. AAPS PharmSciTech. 2005 Dec 6;6(4):E605-17.
Wang K, Li L, Song Y, Ye X, Fu S, Jiang J, Li S
Improvement of pharmacokinetics behavior of apocynin by nitrone derivatization: comparative pharmacokinetics of nitrone-apocynin and its parent apocynin in rats. PLoS One. 2013 Jul 30;8(7):e70189. doi: 10.1

A New Dual Function Oro-Dissolvable/Dispersible Meclizine HCL Tablet to Challenge Patient Inconvenience: In-Vitro Evaluation and In-Vivo Assessment in Human Volunteers

Details for clinical trial NCT04564144

Clinical trial NCT04564144 - References