Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

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

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.

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: Rosuvastatin 10 mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Future Research Center (FRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin 10 mg film coated tablets; Single oral dose of 1 tablet (10 mg)	Drug: Rosuvastatin 10 mg; Film Coated Tablets products containing 10 mg Rosuvastatin
Active Comparator: Crestor® 10 mg film coated tablets; Single oral dose of 1 tablet (10 mg)	Drug: Rosuvastatin 10 mg; Film Coated Tablets products containing 10 mg Rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Rania Mahmoud Mohamed
• Collaborators: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Bioequivalence; Randomized; Rosuvastatin; Cross-Over
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: VIN-B-20-026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No