Healthy IndividualsBENCT05637060
Bioequivalence Study of Rosuvastatin Tablet
A study testing Test Drug and Reference Drug in people with Healthy Individuals, run by University of Karachi at 1 site in Pakistan.
Trial summary
This study is designed to explore the bioequivalence of Test Product Vaptor (Rosuvastatin) 20 mg Tablet with the reference product Crestor (Rosuvastatin) 20 mg tablet under fasting conditions in healthy Pakistani male subjects. 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
- Healthy Individuals
- What is being tested?
- Test Drug and Reference Drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Nov 2022to 15 Dec 2022
- Phase
- Interventional
- 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
- Healthy male volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (ie, blood pressure, heart rate, and temperature), 12 Lead ECG, and laboratory analysis (ie, hematology, blood biochemistry, and urinalysis)and viral serology as determined by the investigator.
- Subjects should have a negative urine test for drugs of abuse (MOP (morphine) and THC (tetrahydrocannabinol) will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects will be able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
Who cannot join
- History of smoking (≥3 cigarettes/day), alcoholism, and test for a drug of abuse, heavy pan or gutka user as judged by teeth/mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subject is allergic to Rosuvastatin and/or other HMG-COA inhibitors.
- Subject has received any investigational drug within 30 days.
- Subjects with salt imbalance in the blood (especially low levels of potassium or magnesium in the blood).
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
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- Ingestion of OTC drug, within 7 days of drug administration.
- History of intake of any prescribed medicine during a period of 30 days, prior to drug administration day of study.
- History of any significant illness in the last four weeks.
- Subjects with a history of renal impairment, liver disease, hypothyroidism, myopathy and rhabdomyolysis.
- Subject taking any vitamins or herbal supplements within the last 14 days of drug administration.
- Subjects who smoke and/or take nicotine in any form. Non-smoking subjects, who have previously smoked, should at least be non-smoking for 6 months prior to dosing.
- Concomitant treatment with cyclosporine, gemfibrozil, Protease Inhibitors (atazanavir and ritonavir, lopinavir and ritonavir or simeprevir), Coumarin Anticoagulant (warfarin), Niacin, Fenofibrate, Colchicine, ezetimibe, erythromycin, an oral contraceptive/ hormone replacement therapy(Ethinyl estradiol and norgestrel), fusidic acid.
- Consumption of grapefruit and/or its products within 14 days prior to the start of study.
- Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
- Individuals having undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible, otherwise by the Principal Investigator or whomever he may designate.
- Inability to take oral medication.
- Subjects with any condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism, or elimination of drugs.
- Subjects with clinically significant abnormalities in investigations (safety assessments) as determined by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Bioequivalence of Vaptor 20mg (Rosuvastatin) Tablet and Crestor 20mg (Rosuvastatin) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects
This study is designed to explore the bioequivalence of Test Product Vaptor (Rosuvastatin) 20 mg Tablet with the reference product Crestor (Rosuvastatin) 20 mg tablet under fasting conditions in healthy Pakistani male subjects.
Read the detailed description
This is a single-center, open-label, randomized, single-dose, two-period, two-way, cross-over study. Subjects will receive one single dose per treatment period of Test and Reference Drugs separated by a wash-out period of 7 days. Blood samples will be taken up to 72 hours post-dose. The primary pharmacokinetic parameters will be compared for both drugs to assess the bioequivalence.
- Conditions
- Healthy Individuals
- Being tested
- Test Drug, Reference Drug
- Keywords
- Bioequivalence Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test DrugDrug
Also called Vaptor 20 mg Tablet
One single dose of Vaptor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time.
Reference DrugDrug
Also called Crestor 20 mg Tablet
One single dose of Crestor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Subjects will take their assigned study medication (Vaptor 20mg), after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time. Those subjects who received Test Drug in first period will receive Reference drug in 2nd period of the study. Receives: Drug: Test Drug; Drug: Reference Drug |
| Reference Group | Active comparator | Subjects will take their assigned study medication (Crestor 20mg), after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time. Those subjects who received Reference Drug in first period will receive Test drug in 2nd period of the study. Receives: Drug: Test Drug; Drug: Reference Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma concentration
maximum drug concentration in plasma after dose
Measured: up to 72 hours post dose
Time to reach maximum plasma concentration
Time required for the drug to reach maximum plasma concentration
Measured: 0 to 72 hours post dose
AUC (Area under concentration vs time curve)
Area under the time versus plasma drug concentration curve
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start24 Nov 2022
- Primary completion6 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A single center, open label, randomized, single-dose, two period, two-way, cross-over study. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- The Searle Company Limited
- Responsible party
- Principal investigator, Dr. Muhammad Raza Shah, University of Karachi
- Investigators
- Muhammad Raza Shah, PhD, Principal investigator, CBSCR, ICCBS, University of Karachi, PakistanNaghma Hashmi (Co-PI), PhD, Principal investigator, CBSCR, ICCBS, University of Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637060
- Sponsor's protocol ID
- CB-027-ROS-2018/Protocol/1.0
- Acronym
- BE
- Status last verified
- Mar 2023
- First submitted
- 24 Nov 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) can be available upon proper request to the Sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Bioequivalence of Vaptor 20mg (Rosuvastatin) Tablet and Crestor 20mg (Rosuvastatin) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects
- ClinicalTrials.gov ID
- NCT05637060
- Acronym / sponsor ID
- BE / CB-027-ROS-2018/Protocol/1.0
- Conditions
- Healthy Individuals
- Keywords
- Bioequivalence Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- The Searle Company Limited
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 5 Dec 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.
This study is designed to explore the bioequivalence of Test Product Vaptor (Rosuvastatin) 20 mg Tablet with the reference product Crestor (Rosuvastatin) 20 mg tablet under fasting conditions in healthy Pakistani male subjects.
Detailed description
This is a single-center, open-label, randomized, single-dose, two-period, two-way, cross-over study. Subjects will receive one single dose per treatment period of Test and Reference Drugs separated by a wash-out period of 7 days. Blood samples will be taken up to 72 hours post-dose. The primary pharmacokinetic parameters will be compared for both drugs to assess the bioequivalence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single center, open label, randomized, single-dose, two period, two-way, cross-over study. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Test Drug, Drug: Reference DrugSubjects will take their assigned study medication (Vaptor 20mg), after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time. Those subjects who received Test Drug in first period will receive Reference drug in 2nd period of the study. |
| Reference Group | Active comparator | Drug: Test Drug, Drug: Reference DrugSubjects will take their assigned study medication (Crestor 20mg), after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time. Those subjects who received Reference Drug in first period will receive Test drug in 2nd period of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (ie, blood pressure, heart rate, and temperature), 12 Lead ECG, and laboratory analysis (ie, hematology, blood biochemistry, and urinalysis)and viral serology as determined by the investigator.
- Subjects should have a negative urine test for drugs of abuse (MOP (morphine) and THC (tetrahydrocannabinol) will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects will be able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
Key exclusion criteria (19 listed)
- History of smoking (≥3 cigarettes/day), alcoholism, and test for a drug of abuse, heavy pan or gutka user as judged by teeth/mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subject is allergic to Rosuvastatin and/or other HMG-COA inhibitors.
- Subject has received any investigational drug within 30 days.
- Subjects with salt imbalance in the blood (especially low levels of potassium or magnesium in the blood).
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 |
|---|---|---|
| Test DrugAlso: Vaptor 20 mg TabletOne single dose of Vaptor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time. | Drug | Reference Group, Test Group |
| Reference DrugAlso: Crestor 20 mg TabletOne single dose of Crestor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time. | Drug | Reference Group, Test Group |
Primary outcome
maximum plasma concentration
Time frame: up to 72 hours post dose
maximum drug concentration in plasma after dose
Time to reach maximum plasma concentration
Time frame: 0 to 72 hours post dose
Time required for the drug to reach maximum plasma concentration
AUC (Area under concentration vs time curve)
Time frame: 0-72 hours
Area under the time versus plasma drug concentration curve
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 22 Mar 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) can be available upon proper request to the Sponsor.
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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.
Muhammad Raza Shah, PhD principal investigator
CBSCR, ICCBS, University of Karachi, Pakistan
Naghma Hashmi (Co-PI), PhD principal investigator
CBSCR, ICCBS, University of Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Drug and Reference Drug in people with Healthy Individuals, run by University of Karachi at 1 site in Pakistan.
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 5 inclusion and 19 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 22 Mar 2023. 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 Pakistan. 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.
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 (time frame: up to 72 hours post dose). 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 22 Mar 2023.