Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

NCT ID: NCT05235217

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2021-06-18

Brief Summary

The current study is conducted to evaluate and compare the relative bioavailability for Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose administration under fasting conditions.

Detailed Description

A randomized, single-dose, two-treatment, partial replicate, three-phase, three-sequence, bioequivalence study of the two study products. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Esomeprazole plasma concentrations were analyzed using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the concentrations obtained using Phoenix WinNonlin® software.

Conditions

Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Test product (T) 40 mg Hard Gelatin Capsules

Single oral dose of 40 mg capsule

Group Type: EXPERIMENTAL

Test product (T) 40 mg Hard Gelatin Capsules

Intervention Type: DRUG

Hard Gelatin Capsules products containing 40 mg Esomeprazole

Reference product (R) 40 mg Hard Gelatin Capsules (first dose)

Single oral dose of 40 mg capsule

Group Type: ACTIVE_COMPARATOR

Reference product (R) 40 mg Hard Gelatin Capsules

Intervention Type: DRUG

Reference product (R) 40 mg Hard Gelatin Capsules

Reference product (R) 40 mg Hard Gelatin Capsules (second dose)

Single oral dose of 40 mg capsule

Group Type: ACTIVE_COMPARATOR

Reference product (R) 40 mg Hard Gelatin Capsules

Intervention Type: DRUG

Reference product (R) 40 mg Hard Gelatin Capsules

Interventions

Test product (T) 40 mg Hard Gelatin Capsules

Hard Gelatin Capsules products containing 40 mg Esomeprazole

Intervention Type: DRUG

Reference product (R) 40 mg Hard Gelatin Capsules

Reference product (R) 40 mg Hard Gelatin Capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent is obtained for study.
• Age 18 - 55 years,
• Body mass index between 18.5 and 30 kg/m2
• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
• Vital signs without significant deviations.
• All laboratory screening results are within the normal range or clinically non-significant

Exclusion Criteria

• History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
• History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
• Any confirmed significant allergic reactions against any drug, or multiple allergies.
• Clinically significant illness 28 days before study period I.
• Alcohol or any solvent intake.
• Regular use of medication.
• Positive urine screening of drugs of abuse.
• Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
• History or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
• Blood donation within the past 60 days.
• Participation in another bioequivalence study within 60 days prior to the start of period I of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

Hala Masoud

FRC Technical Director & CEO

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Future Research Center (FRC)

Cairo, , Egypt

Countries

Egypt

Other Identifiers

RAZ-B-21-046

Identifier Type: -

Identifier Source: org_study_id