Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

Bioequivalence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235217
• Other study ID #: RAZ-B-21-046
• Status: Completed
• Phase: Phase 1
• Start date: June 3, 2021
• Est. completion date: June 18, 2021

Study information

• Verified date: January 2022
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• Test product (T) 40 mg Hard Gelatin Capsules
Hard Gelatin Capsules products containing 40 mg Esomeprazole
• Reference product (R) 40 mg Hard Gelatin Capsules
Reference product (R) 40 mg Hard Gelatin Capsules

Locations

Country	Name	City	State
Egypt	Future Research Center (FRC)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Maximum time (Tmax)	Time until Cmax is reached	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	Elimination Rate Constant (Kel)	Kel is a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system	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	Plasma concentration half-life (t1/2)	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.	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