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)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Stomopral; Drug: Nexium

• Registration Number: NCT05038969
• Lead Sponsor: Genuine Research Center, Egypt

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-18
• Primary Completion: 2021-04-01
• Study Completion: 2021-05-28
• Status Verified: 2021-09
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-06
• Last Update Submitted: 2021-09-06
• Study First Posted: 2021-09-09
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A test	Stomopral	Test drug (Stomopral) 1 capsule contains 40 mg Enteric Coated Pellets of Esomeprazole
B reference	Nexium	Reference drug (Nexium) 1 capsule contains 40 mg Esomeprazole

Primary Outcome Measures

Name	Time	Method
Cmax	Up to12 hours post dose in each treatment period	Maximal measured plasma concentration

Secondary Outcome Measures

Name	Time	Method
Time of the maximum plasma concentration (Tmax)	Up to12 hours post dose in each treatment period	The amount of time that a drug is present at the maximum concentration in serum

Trial Locations

Locations (1)

Genuine Research Center GRC; 🇪🇬 Cairo, Egypt