Overview

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)

Status:
Completed
Trial end date:
2021-05-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Genuine Research Center, Egypt
Collaborator:
Future Pharmaceuticals Industries, Egypt
Treatments:
Esomeprazole
Criteria
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.