BioequivalencePhase 1NCT05197517
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition
A Phase 1 study testing Rosuvastatin 10 mg in people with Bioequivalence, run by Rania Mahmoud Mohamed at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Rosuvastatin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2020to 1 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Bioequivalence
- Being tested
- Rosuvastatin 10 mg
- Keywords
- Rosuvastatin, Bioequivalence, Randomized, Cross-Over
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 10 mgDrug
Film Coated Tablets products containing 10 mg Rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 10 mg film coated tablets | Experimental | Single oral dose of 1 tablet (10 mg) Receives: Drug: Rosuvastatin 10 mg |
| Crestor® 10 mg film coated tablets | Active comparator | Single oral dose of 1 tablet (10 mg) Receives: Drug: Rosuvastatin 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Cmax is observed as the maximum of Rosuvastatin peak concentration
Measured: 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).
Measured: 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")
Measured: Pre-dose to infinite time
Secondary outcomes (3)
Maximum time (Tmax)
Time until Cmax is reached
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start21 Sep 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania Mahmoud Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Future University in Egypt
- Responsible party
- Sponsor-investigator, Rania Mahmoud Mohamed, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197517
- Sponsor's protocol ID
- VIN-B-20-026
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05197517
- Acronym / sponsor ID
- VIN-B-20-026
- Conditions
- Bioequivalence
- Keywords
- Rosuvastatin, Bioequivalence, Randomized, Cross-Over
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rania Mahmoud MohamedUniversity, hospital or other
- Collaborators
- Future University in Egypt
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 10 mg film coated tablets | Experimental | Drug: Rosuvastatin 10 mgSingle oral dose of 1 tablet (10 mg) |
| Crestor® 10 mg film coated tablets | Active comparator | Drug: Rosuvastatin 10 mgSingle oral dose of 1 tablet (10 mg) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 10 mgFilm Coated Tablets products containing 10 mg Rosuvastatin | Drug | Crestor® 10 mg film coated tablets, Rosuvastatin 10 mg film coated tablets |
Primary outcome
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
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).
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")
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin 10 mg in people with Bioequivalence, run by Rania Mahmoud Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.