Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

Bioequivalence Clinical Trial

Official title:

A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the Two Different Products Containing 10 mg Film Coated Tablet After Oral Administration to 38 Healthy Adult Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197517
• Other study ID #: VIN-B-20-026
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2020
• Est. completion date: October 1, 2020

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 present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.

Description:

A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the two different products containing 10 mg film coated tablet after oral administration to 38 healthy adult volunteers under fasting conditions. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Plasma concentrations of Rosuvastatin were analyzed and determined using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 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 phase 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 phase I of the study.

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• Rosuvastatin 10 mg
Film Coated Tablets products containing 10 mg Rosuvastatin

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Rania Mahmoud Mohamed	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 Rosuvastatin peak concentration	Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
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 and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
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 to infinite time
Secondary	Maximum time (Tmax)	Time until Cmax is reached	Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
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 and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours
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 and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours