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)

NCT04854538 | Completed Phase 1

• 1 other identifier: GRC/1/20/836
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Cmax

  Maximal measured plasma concentration

  Up to 72 hours post dose in each treatment period

Secondary Outcomes (1)

• Time of the maximum plasma concentration (Tmax)

  Up to 72 hours post dose in each treatment period

Study Arms (3)

T test

EXPERIMENTAL

Test drug (Ekmasonid) 1 tablet contains 9 mg Budesonide

Drug: Ekmasonid

B reference (first dose)

EXPERIMENTAL

Reference drug (Uceris) 1 tablet contains 9 mg Budesonide

Drug: Uceris (first dose)

B reference (second dose)

EXPERIMENTAL

Reference drug (Uceris) 1 tablet contains 9 mg Budesonide

Drug: Uceris (second dose)

Interventions

Ekmasonid DRUG

1 extended release tablet contains 9 mg Budesonide

Also known as: Uceris

T test

Uceris (first dose) DRUG

1 extended release tablet contains 9 mg Budesonide

Also known as: Uceris

B reference (first dose)

Uceris (second dose) DRUG

1 extended release tablet contains 9 mg Budesonide

Also known as: Uceris

B reference (second dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, age 18 to 55 years, inclusive.
• Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
• Medical demographics without evidence of clinically significant deviation from normal medical condition.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Subject does not have allergy to the drugs under investigation.
• Females should be on a suitable birth control method.

You may not qualify if:

• Subjects with known allergy to the products tested.
• Subjects whose values of BMI were outside the accepted normal ranges.
• Female subjects who were pregnant or nursing.
• Medical demographics with evidence of clinically significant deviation from normal medical condition.
• Results of laboratory tests which are clinically significant.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• 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.
• Subject is on a special diet (for example subject is vegetarian).
• 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.
• 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.
• Subject has a history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
• Subject intends to be hospitalized within 3 months after first study drug administration.
• 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.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Hikma Pharmaceuticals LLC: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, Egypt

Location

Related Publications (3)

• 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.

  PMID: 11381568 BACKGROUND

• 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.

  PMID: 2004861 BACKGROUND

• 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.

  PMID: 3450848 BACKGROUND

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: September 17, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 4, 2020
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)