Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

NCT05235217 | Completed Phase 1

• 1 other identifier: RAZ-B-21-046
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence

Keywords

Esomeprazole; Bioequivalence; Randomized; Replicate

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration (Cmax)

  Cmax is observed as the maximum of Esomeprazole peak concentration

  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

• Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t))

  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)

  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

• Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))

  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")

  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

Secondary Outcomes (3)

• Maximum time (Tmax)

  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

• Elimination Rate Constant (Kel)

  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

• Plasma concentration half-life (t1/2)

  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

Study Arms (3)

Test product (T) 40 mg Hard Gelatin Capsules

EXPERIMENTAL

Single oral dose of 40 mg capsule

Drug: Test product (T) 40 mg Hard Gelatin Capsules

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

ACTIVE COMPARATOR

Single oral dose of 40 mg capsule

Drug: Reference product (R) 40 mg Hard Gelatin Capsules

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

ACTIVE COMPARATOR

Single oral dose of 40 mg capsule

Drug: Reference product (R) 40 mg Hard Gelatin Capsules

Interventions

Test product (T) 40 mg Hard Gelatin Capsules DRUG

Hard Gelatin Capsules products containing 40 mg Esomeprazole

Test product (T) 40 mg Hard Gelatin Capsules

Reference product (R) 40 mg Hard Gelatin Capsules DRUG

Reference product (R) 40 mg Hard Gelatin Capsules

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

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future Research Center (FRC)

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FRC Technical Director & CEO

Model Details: A randomized, single-dose, partial replicate crossover, three-phase, three-sequence, two treatments bioequivalence study.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 11, 2022
• Study Start: June 3, 2021
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-01

Locations

EG (1)