HypercholesterolaemiaPhase 1NCT01711749
Rosuvastatin Calcium Bioequivalence Study - Fast
A Phase 1 study testing Crestor® and rosuvastatin calcium tablets in people with Hypercholesterolaemia, run by GlaxoSmithKline at 1 site in Brazil.
Trial summary
This is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if both formulations are bioequivalent. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- Crestor® and rosuvastatin calcium tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Feb 2013to 13 Mar 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman aged between 18 to 50 years. Women can not be pregnant nor breastfeeding, and man and woman commit to use an efficient contraceptive method along the entire study period;
- Volunteers of Asian descent, due to differences in the pharmacokinetics of rosuvastatin in this group of people;
- Volunteers cholecystectomy;
- Female subjects of childbearing potential must not become pregnant during the study period, thus, should be sexually inactive through abstinence or use of contraceptive methods the failure rate <1%. Inactivity sexual abstinence should be consistent with the usual lifestyle of the subject. Periodic abstinence and withdrawal are not acceptable methods of contraception. Will be accepted as methods of contraception with failure rate less than 1%: oral contraceptives, either combined or progestogen alone, injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, Percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system (IUS ) that meets the failure rate <1%, double barrier method, partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject;
- Body mass index ≥ 18.5 or ≤ 29.9 kg/m²;
- Volunteers with good health conditions and without significant diseases at medical criterion, as per the Clinical History; Blood pressure, pulse and temperature are taken, Physical examination, ECG and complementary Lab examinations;
- The volunteer is healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study;
- The volunteer must be able to understand nature and purpose of the study, including the risks and adverse effects and must show good intention to cooperate with the researcher and act according to the requirement of the entire trial, what is confirmed by the signature of an Informed Consent.
Who cannot join
- The volunteer has a known hypersensitivity to the drug being studied or to any chemically related compounds;
- History or existence of hepatic or GI diseases or any other condition that could interfere with the absorption, distribution, excretion or metabolism of the drug;
- Use of maintenance therapy with any drug but oral contraceptives;
- History of hepatic, renal, pulmonary, GI, neurological, hematological, psychiatric, cardiologic or allergic problem of any etiology that needs drug treatment or that the researcher considers it is clinically relevant;
- Current or chronic history of liver disease, or know hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstone);
- ECG findings, not recommended at the researcher's criterion to participate in the study;
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- Results of complementary lab tests that are out of the values considered normal, according to this protocol guidelines, unless the researcher considers them non-clinically significant;
- Smoke abuse;
- Daily ingestion of more than five cups of coffee;
- History of alcohol or drug abuse;
- Use of regular medication along the two weeks that preceded the study commencement, or use of any other medication one week before the study commencement;
- Hospitalization for any reason up to 8 weeks before the first period of study;
- Treatment along three months before the treatment commencement of the study with any drug known because of its well-defined toxic potential to major organs;
- Participation in any pharmacokinetics study with collection of more than 300 mL of blood or ingestion of any experimental drug along six months before the treatment commencement of the study;
- Donation or loss of ≥ 450 mL of blood along the three months that preceded the study or donation of more than 1500 mL along the 12 months before the treatment commencement of the study;
- Positive result for βHCG in urine in female volunteer;
- A positive pre-study Hepatitis B surface antigen or positive Hepatites C antibody result within 3 months os screening;
- Female subjects not using a contraceptive method that meets the failure rate <1%;
- Any condition that prevents the participation in the study, according to the researcher's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Bioequivalence Between Two Formulations of 20 mg Rosuvastatin Calcium Tablets, Administered Under Fasting to Healthy Volunteers of Both Genders, Being the Test Formulation Manufactured by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda. and the Reference Formulation (Crestor®) Commercialized by AstraZeneca do Brasil Ltda.
This is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if both formulations are bioequivalent.
Read the detailed description
The objective of this study is to confirm if two formulations of rosuvastatin calcium 20 mg tablets are bioequivalent. Test formulation is rosuvastatin calcium 20 mg tablets - manufactured by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brazil Ltda., administration of one single-dose tablet. Reference formulation is rosuvastatin calcium 20 mg tablets (Crestor® 20 mg - AstraZeneca do Brasil Ltda.), administration of one single-dose tablet. Sixty-four healthy volunteers, of both genders, with age ranging from 18 and 50 years old, will receive test or reference formulation under fasting conditions, according to the randomization list. In each period, after administration of medication, blood samples are collected at the following times: 0:00 (prior to administration), 0:30, 1:00, 1:30, 2:00, 2:20, 2:40: 3:00, 3:20, 3:40, 4:00, 4:20, 4:40, 5:00, 5:30, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 and 72:00 hours. The comparative bioavailability of formulations is evaluated based on relevant pharmacokinetic parameters for statistical comparison. Such parameters are obtained directly from the determination of the drug active principle plasmatic concentration, based on the application of a non-compartmental pattern for the evaluation of these concentrations after the drug oral administration.
- Conditions
- Hypercholesterolaemia
- Being tested
- Crestor®, rosuvastatin calcium tablets
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crestor®Drug
Reference formulation is rosuvastatin calcium tablets, 20mg, currently commercialized by AstraZeneca do Brasil Ltda., under the trademark Crestor®
rosuvastatin calcium tabletsDrug
Test formulation is rosuvastatin calcium tablets, 20 mg, produced by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Active comparator | 01 tablet, single dose, of Reference Product in period 1 and 01 tablet, single dose, of Test Product in period 2. Receives: Drug: Crestor®; Drug: rosuvastatin calcium tablets |
| Sequence 2 | Active comparator | 01 tablet of Test Product in period 1, and 01 tablet, single dose, of Reference Product in period 2. Receives: Drug: Crestor®; Drug: rosuvastatin calcium tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve 0-t (AUC)
Drug concentration area under the curve versus time, calculated by trapezoidal methods of time 0 to time t, where t is the time related to the last drug concentration, experimentally determined above the Quantification Limit (QL).
Measured: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Area Under the Curve 0-infinite (AUC)
Drug concentration area under the curve versus time, (time 0) infinite-extrapolated, where AUC[0-infinite] = AUC[0-t] + Ct/k, where Ct is the last drug concentration, experimentally determined (above the quantification limit) in that k is the terminal phase clearance constant.
Measured: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Half Life (T1/2)
Half life is calculated as ln(2) / k
Measured: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Maximum concentration (Cmax)
Maximum concentration reached after drug administration
Measured: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Time to Cmax (Tmax)
Time to obtain the maximum concentration
Measured: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study start25 Feb 2013
- Primary completion13 Mar 2013
- Study completion13 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711749
- Sponsor's protocol ID
- 117120
- Status last verified
- Jun 2017
- First submitted
- 18 Oct 2012
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bioequivalence Between Two Formulations of 20 mg Rosuvastatin Calcium Tablets, Administered Under Fasting to Healthy Volunteers of Both Genders, Being the Test Formulation Manufactured by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda. and the Reference Formulation (Crestor®) Commercialized by AstraZeneca do Brasil Ltda.
- ClinicalTrials.gov ID
- NCT01711749
- Acronym / sponsor ID
- 117120
- Conditions
- Hypercholesterolaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2013 (actual)
- Primary completion
- 13 Mar 2013 (actual)
- Study completion
- 13 Mar 2013 (actual)
- First posted
- 22 Oct 2012 (estimated)
- 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 is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if both formulations are bioequivalent.
Detailed description
The objective of this study is to confirm if two formulations of rosuvastatin calcium 20 mg tablets are bioequivalent. Test formulation is rosuvastatin calcium 20 mg tablets - manufactured by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brazil Ltda., administration of one single-dose tablet. Reference formulation is rosuvastatin calcium 20 mg tablets (Crestor® 20 mg - AstraZeneca do Brasil Ltda.), administration of one single-dose tablet. Sixty-four healthy volunteers, of both genders, with age ranging from 18 and 50 years old, will receive test or reference formulation under fasting conditions, according to the randomization list. In each period, after administration of medication, blood samples are collected at the following times: 0:00 (prior to administration), 0:30, 1:00, 1:30, 2:00, 2:20, 2:40: 3:00, 3:20, 3:40, 4:00, 4:20, 4:40, 5:00, 5:30, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 and 72:00 hours. The comparative bioavailability of formulations is evaluated based on relevant pharmacokinetic parameters for statistical comparison. Such parameters are obtained directly from the determination of the drug active principle plasmatic concentration, based on the application of a non-compartmental pattern for the evaluation of these concentrations after the drug oral administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Active comparator | Drug: Crestor®, Drug: rosuvastatin calcium tablets01 tablet, single dose, of Reference Product in period 1 and 01 tablet, single dose, of Test Product in period 2. |
| Sequence 2 | Active comparator | Drug: Crestor®, Drug: rosuvastatin calcium tablets01 tablet of Test Product in period 1, and 01 tablet, single dose, of Reference Product in period 2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Man or woman aged between 18 to 50 years. Women can not be pregnant nor breastfeeding, and man and woman commit to use an efficient contraceptive method along the entire study period;
- Volunteers of Asian descent, due to differences in the pharmacokinetics of rosuvastatin in this group of people;
- Volunteers cholecystectomy;
- Female subjects of childbearing potential must not become pregnant during the study period, thus, should be sexually inactive through abstinence or use of contraceptive methods the failure rate <1%. Inactivity sexual abstinence should be consistent with the usual lifestyle of the subject. Periodic abstinence and withdrawal are not acceptable methods of contraception. Will be accepted as methods of contraception with failure rate less than 1%: oral contraceptives, either combined or progestogen alone, injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, Percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system (IUS ) that meets the failure rate <1%, double barrier method, partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject;
- Body mass index ≥ 18.5 or ≤ 29.9 kg/m²;
Key exclusion criteria (19 listed)
- The volunteer has a known hypersensitivity to the drug being studied or to any chemically related compounds;
- History or existence of hepatic or GI diseases or any other condition that could interfere with the absorption, distribution, excretion or metabolism of the drug;
- Use of maintenance therapy with any drug but oral contraceptives;
- History of hepatic, renal, pulmonary, GI, neurological, hematological, psychiatric, cardiologic or allergic problem of any etiology that needs drug treatment or that the researcher considers it is clinically relevant;
- Current or chronic history of liver disease, or know hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstone);
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 |
|---|---|---|
| Crestor®Reference formulation is rosuvastatin calcium tablets, 20mg, currently commercialized by AstraZeneca do Brasil Ltda., under the trademark Crestor® | Drug | Sequence 1, Sequence 2 |
| rosuvastatin calcium tabletsTest formulation is rosuvastatin calcium tablets, 20 mg, produced by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda. | Drug | Sequence 1, Sequence 2 |
Primary outcome
Area Under the Curve 0-t (AUC)
Time frame: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Drug concentration area under the curve versus time, calculated by trapezoidal methods of time 0 to time t, where t is the time related to the last drug concentration, experimentally determined above the Quantification Limit (QL).
Area Under the Curve 0-infinite (AUC)
Time frame: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Drug concentration area under the curve versus time, (time 0) infinite-extrapolated, where AUC[0-infinite] = AUC[0-t] + Ct/k, where Ct is the last drug concentration, experimentally determined (above the quantification limit) in that k is the terminal phase clearance constant.
Half Life (T1/2)
Time frame: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Half life is calculated as ln(2) / k
Maximum concentration (Cmax)
Time frame: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Maximum concentration reached after drug administration
Time to Cmax (Tmax)
Time frame: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.
Time to obtain the maximum concentration
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 Jun 2017.
- Results for study 117120 can be found on the GSK Clinical Study Register.Link provided by 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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Crestor® and rosuvastatin calcium tablets in people with Hypercholesterolaemia, run by GlaxoSmithKline at 1 site in Brazil.
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 8 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 20 Jun 2017. 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 Brazil. 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?
Area Under the Curve 0-t (AUC) (time frame: Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.). The study lists 5 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 Jun 2017.