Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

• ClinicalTrials.gov Identifier: NCT05235217
• Recruitment Status: Completed
• First Posted: February 11, 2022
• Last Update Posted: February 11, 2022
• Sponsor: Future University in Egypt
• Information provided by (Responsible Party): Hala Masoud, Future University in Egypt

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bioequivalence	Drug: Test product (T) 40 mg Hard Gelatin Capsules; Drug: Reference product (R) 40 mg Hard Gelatin Capsules	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A randomized, single-dose, partial replicate crossover, three-phase, three-sequence, two treatments bioequivalence study.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Randomized, Single-Dose, Partial Replicate, Three-period, Three-sequence, Open-Label, Bioequivalence Study Comparing Esomeprazole in Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions
• Actual Study Start Date: June 3, 2021
• Actual Primary Completion Date: June 18, 2021
• Actual Study Completion Date: June 18, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test product (T) 40 mg Hard Gelatin Capsules; Single oral dose of 40 mg capsule	Drug: Test product (T) 40 mg Hard Gelatin Capsules; Hard Gelatin Capsules products containing 40 mg Esomeprazole
Active Comparator: Reference product (R) 40 mg Hard Gelatin Capsules (first dose); Single oral dose of 40 mg capsule	Drug: Reference product (R) 40 mg Hard Gelatin Capsules; Reference product (R) 40 mg Hard Gelatin Capsules
Active Comparator: Reference product (R) 40 mg Hard Gelatin Capsules (second dose); Single oral dose of 40 mg capsule	Drug: Reference product (R) 40 mg Hard Gelatin Capsules; Reference product (R) 40 mg Hard Gelatin Capsules

Outcome Measures

Primary Outcome Measures :

1. Maximum plasma concentration (Cmax) [ Time Frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose ]
   Cmax is observed as the maximum of Esomeprazole peak concentration
2. Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t)) [ Time Frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose ]
   The AUC (0-t) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast)
3. Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf)) [ Time Frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose ]
   AUC(0-inf) "the area under the curve," which is a way of measuring the total amount of the active drug in a subject's system over a period of time from administration ("0") to the time that the drug is no longer present in the subject's body ("infinity")

Secondary Outcome Measures :

1. Maximum time (Tmax) [ Time Frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose ]
   Time until Cmax is reached
2. Elimination Rate Constant (Kel) [ Time Frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose ]
   Kel is a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system
3. Plasma concentration half-life (t1/2) [ Time Frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose ]
   t1/2 is the time taken for the plasma concentration of a drug to reduce to half its original value. It is used to estimate how long it takes for a drug to be removed from your body.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 44 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

Future Research Center (FRC)

Cairo, Egypt

Sponsors and Collaborators

Future University in Egypt

More Information

• Responsible Party: Hala Masoud, FRC Technical Director & CEO, Future University in Egypt
• ClinicalTrials.gov Identifier: NCT05235217
• Other Study ID Numbers: RAZ-B-21-046
• First Posted: February 11, 2022
• Last Update Posted: February 11, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hala Masoud, Future University in Egypt:

Esomeprazole; Bioequivalence; Randomized; Replicate