Relative Bioavailability Clinical Trial
Official title:
A Phase 1, Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS)
This study is to compare the systemic exposure of budesonide delivered by the combination inhaler (budesonide/albuterol sulfate pressurized inhalation suspension [BDA metered dose inhaler {BDA MDI}]) with Pulmicort Flexhaler dry-powder inhaler (DPI).
This study will be an open-label, randomized, 2-way cross-over study in healthy adult male or female participants, performed at a single study center.Participants will receive single doses of BDA MDI or Pulmicort Flexhaler on 2 occasions, under fasted conditions. There will be a minimum washout period of 3 days between each dose administration. A total of 66 participants will be randomized in this study to ensure that at least 62 participants are evaluable. The study will comprise of screening period of maximum 27 days; Two treatment periods during which participants will be resident from the day prior to administration of budesonide/albuterol sulfate pressurized inhalation suspension metered dose inhaler (BDA MDI) or Pulmicort Flexhaler (Day -1) until at least 24 hours after dosing. Participants will be discharged on the morning of Day 2; and a final follow-up visit within 5 to 7 days after the last administration of BDA MDI or Pulmicort Flexhaler. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02052349 -
Bioavailability of ABT-333 Within the Gastrointestinal Tract in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01911741 -
A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT03154840 -
Relative Bioavailability Among Different Eutropin Formulations
|
Phase 1 | |
| Completed |
NCT04814472 -
Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations
|
Phase 1 | |
| Not yet recruiting |
NCT06025318 -
An Evaluation of the Effect of Food on the PK of a Novel PanCytoVir™ Suspension (100mg/ml), in Healthy, Adult Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT06025344 -
A Relative Bioavailability Study With a Novel PanCytoVir™ Oral Suspension (100 mg/ml)
|
Phase 1 | |
| Completed |
NCT04686669 -
A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations
|
Phase 1 | |
| Completed |
NCT03483259 -
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers
|
Phase 1 | |
| Completed |
NCT05296382 -
Bioavailability of Tebipenem (SPR994) Crushed Tablet
|
Phase 1 |