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)
NCT ID: NCT04854538
Last Updated: 2021-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2020-09-17
2020-12-04
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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T test
Test drug (Ekmasonid) 1 tablet contains 9 mg Budesonide
Ekmasonid
1 extended release tablet contains 9 mg Budesonide
B reference (first dose)
Reference drug (Uceris) 1 tablet contains 9 mg Budesonide
Uceris (first dose)
1 extended release tablet contains 9 mg Budesonide
B reference (second dose)
Reference drug (Uceris) 1 tablet contains 9 mg Budesonide
Uceris (second dose)
1 extended release tablet contains 9 mg Budesonide
Interventions
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Ekmasonid
1 extended release tablet contains 9 mg Budesonide
Uceris (first dose)
1 extended release tablet contains 9 mg Budesonide
Uceris (second dose)
1 extended release tablet contains 9 mg Budesonide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
3. Medical demographics without evidence of clinically significant deviation from normal medical condition.
4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
5. Subject does not have allergy to the drugs under investigation.
6. Females should be on a suitable birth control method.
Exclusion Criteria
2. Subjects whose values of BMI were outside the accepted normal ranges.
3. Female subjects who were pregnant or nursing.
4. Medical demographics with evidence of clinically significant deviation from normal medical condition.
5. Results of laboratory tests which are clinically significant.
6. Acute infection within one week preceding first study drug administration.
7. History of drug or alcohol abuse.
8. Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
9. Subject is on a special diet (for example subject is vegetarian).
10. Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
11. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
12. Subject has a history of severe diseases which have direct impact on the study.
13. Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
14. Subject intends to be hospitalized within 3 months after first study drug administration.
15. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
18 Years
55 Years
ALL
Yes
Sponsors
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Hikma Pharmaceuticals LLC
INDUSTRY
Genuine Research Center, Egypt
INDUSTRY
Responsible Party
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Principal Investigators
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Ahmed Elshafeey, Ph.D. Pharma
Role: STUDY_DIRECTOR
Genuine Research Center
Locations
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Genuine Research Center GRC
Cairo, , Egypt
Countries
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References
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Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.
Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
Other Identifiers
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GRC/1/20/836
Identifier Type: -
Identifier Source: org_study_id
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