Trials / Completed
CompletedNCT04854538
Bioequivalence Study of Budesonide From Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) Versus Uceris 9 mg Extended Release Tablets (Man. for: Salix Pharm., a Division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by License of Cosmo Tech. Ltd., Ireland, Product of France)
An Open Label Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study to Determine the Bioequivalence of Budesonide From Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) Versus Uceris 9 mg Extended Release Tablets (Man. for: Salix Pharm., a Division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by License of Cosmo Tech. Ltd., Ireland, Product of France)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Genuine Research Center, Egypt · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Budesonide from Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) versus Uceris 9 mg Extended Release tablets (Man. for: Salix Pharm., a division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by license of Cosmo Tech. Ltd., Ireland, Product of France) in Healthy Human Volunteers Under Fasting Condition.
Detailed description
Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ekmasonid | 1 extended release tablet contains 9 mg Budesonide |
| DRUG | Uceris (first dose) | 1 extended release tablet contains 9 mg Budesonide |
| DRUG | Uceris (second dose) | 1 extended release tablet contains 9 mg Budesonide |
Timeline
- Start date
- 2020-09-17
- Primary completion
- 2020-10-01
- Completion
- 2020-12-04
- First posted
- 2021-04-22
- Last updated
- 2021-04-22
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04854538. Inclusion in this directory is not an endorsement.