Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France)

Healthy Clinical Trial

Official title:

Comparative Randomized, Single Dose,Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038969
• Other study ID #: GRC/1/20/868
• Status: Completed
• Phase: Phase 1
• Start date: March 18, 2021
• Est. completion date: May 28, 2021

Study information

• Verified date: September 2021
• Source: Genuine Research Center, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparative randomized, single dose Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) in Healthy Human Volunteers Under Fasting Condition.

Description:

Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. Minimum of 24 subjects will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report. 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, AUC0-72 and AUC0-∞ for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0-72 and AUC0-∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 28, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy male or female, age 18 to 55 years, inclusive.

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, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.

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. Females should be on a suitable birth control method.

6. Fully informed subjects that consented to participate in the study.

Exclusion Criteria:

1. Subjects with known allergy to the products tested.

2. Female subjects who were pregnant or nursing.

3. Acute infection within one week preceding first study drug administration.

4. History of drug or alcohol abuse.

5. Subject does not comply with the stated instruction of not taking any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.

6. Subject is on a special diet (for example subject is vegetarian).

7. 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.

8. 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.

9. Subject has a family history of severe diseases which have direct impact on the study.

10. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.

11. Subject intends to be hospitalized within 3 months after first study drug administration.

12. Subjects who has blood donated or lost more than 500 mL blood within 3 months prior to the study.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Stomopral
1 capsule contains 40 mg Esomeprazole
• Nexium
1 capsule contains 40 mg Esomeprazole

Locations

Country	Name	City	State
Egypt	Genuine Research Center GRC	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Genuine Research Center, Egypt	Future Pharmaceuticals Industries, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. Erratum in: J Pharmacokinet Pharmacodyn. 2002 Feb;29(1):101.. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximal measured plasma concentration	Up to12 hours post dose in each treatment period
Secondary	Time of the maximum plasma concentration (Tmax)	The amount of time that a drug is present at the maximum concentration in serum	Up to12 hours post dose in each treatment period

External Links

•   Note for Guidance on Clinical Safety Data Management; Definitions And Standards for Expedited Reporting (CPMP/ICH/377/95) The European Agency for the Evaluation of Medicinal Products (EMEA) June 1995.
•   Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) The European Agency for the Evaluation of Medicinal Products (EMEA) May 1997