Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

• ClinicalTrials.gov Identifier: NCT05197517
• Recruitment Status: Completed
• First Posted: January 19, 2022
• Last Update Posted: January 20, 2022
• Sponsor: Rania Mahmoud Mohamed
• Collaborator: Future University in Egypt
• Information provided by (Responsible Party): Rania Mahmoud Mohamed, Future University in Egypt

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Bioequivalence	Drug: Rosuvastatin 10 mg	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: September 21, 2020
• Actual Primary Completion Date: October 1, 2020
• Actual Study Completion Date: October 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Maximum plasma concentration (Cmax) [ Time Frame: 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 ]
   Cmax is observed as the maximum of Rosuvastatin 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 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 ]
   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 to infinite time ]
   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 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 ]
   Time until Cmax is reached
2. Elimination Rate Constant (Kel) [ Time Frame: 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 ]
   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 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 ]
   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 55 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 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.

Contacts and Locations

Locations

Egypt

Future Research Center (FRC)

Cairo, Egypt

Sponsors and Collaborators

Rania Mahmoud Mohamed

Future University in Egypt

More Information

• Responsible Party: Rania Mahmoud Mohamed, Unit director at FRC, Future University in Egypt
• ClinicalTrials.gov Identifier: NCT05197517
• Other Study ID Numbers: VIN-B-20-026
• First Posted: January 19, 2022
• Last Update Posted: January 20, 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 Rania Mahmoud Mohamed, Future University in Egypt:

Rosuvastatin; Bioequivalence; Randomized; Cross-Over

Additional relevant MeSH terms:

Rosuvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors