Pharmacokinetics Clinical Trial
Official title:
A Randomized, Open Label, Single-center, Single-dose, Four-period Crossover Clinical Trial to Assess the PK Profile and Safety of Budesonide Inhalation Solution AQ001S Compared to Budesonide Inhalation Suspension in Healthy Volunteers
This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.
This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers. Three (3) different AQ001S concentrations (i.e. 0.125 mg/2 mL, 0.250 mg/2mL and 0.500 mg/2 mL) will be compared to budesonide inhalation suspension 1.0 mg/2 ml. Twenty (20) male and female healthy volunteers, from 18 to 60 years old, must complete the study. The study drug will be administered by nebulization. The primary PK objective is to characterize the pharmacokinetic (PK) profile of AQ001S inhalation solution. The primary safety objective is to assess the safety of AQ001S inhalation solution. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04092725 -
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04181008 -
Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
|
Early Phase 1 | |
| Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
| Completed |
NCT04406415 -
Oral Nafamostat in Healthy Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT05421312 -
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip
|
Phase 4 | |
| Completed |
NCT02534753 -
A Pharmacokinetics Study of Intravenous Ascorbic Acid
|
Phase 1 | |
| Completed |
NCT01682408 -
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
|
Phase 1 | |
| Completed |
NCT01976078 -
Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
|
N/A | |
| Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
| Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
| Completed |
NCT01214941 -
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
|
Phase 4 | |
| Completed |
NCT01208155 -
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
|
Phase 1 | |
| Completed |
NCT01260025 -
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
|
Phase 1 | |
| Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
| Completed |
NCT00746499 -
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
|
Phase 1 | |
| Completed |
NCT00730145 -
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
|
Phase 1 | |
| Completed |
NCT00856570 -
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01276119 -
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
|
Phase 1 | |
| Completed |
NCT01055964 -
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
|
Phase 3 | |
| Completed |
NCT00983242 -
Drug-Drug Interaction Between Colchicine and Verapamil ER
|
Phase 1 |