Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Crestor · 1 trial · 1 indication
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).
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 is calculated as ln(2) / k
Maximum concentration reached after drug administration
Time to obtain the maximum concentration
| Arm | Type | Description |
|---|---|---|
| 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. |
| Sequence 2 | ACTIVE_COMPARATOR | 01 tablet of Test Product in period 1, and 01 tablet, single dose, of Reference Product in period 2. |
| Name | Type | Description |
|---|---|---|
| Crestor® | DRUG | Reference formulation is rosuvastatin calcium tablets, 20mg, currently commercialized by AstraZeneca do Brasil Ltda., under the trademark Crestor® |
| rosuvastatin calcium tablets | DRUG | Test formulation is rosuvastatin calcium tablets, 20 mg, produced by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda. |
Inclusion Criteria: * 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 ...
Crestor is used for hypercholesterolaemia, a condition of high cholesterol levels in the blood. It is being investigated as a treatment for this metabolic disorder. The drug is currently in clinical development, with studies evaluating its effects in patients with this condition.
Crestor is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this drug for the treatment of hypercholesterolaemia.
Crestor is in Phase 1 of clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
Crestor has one completed clinical trial with the identifier NCT01711749. This was a Phase 1 bioequivalence study conducted in Brazil with 60 participants, all healthy volunteers. The trial was active-controlled and randomized, though it was not double-blind.
Crestor is being studied as rosuvastatin calcium in clinical trials. The completed Phase 1 trial, NCT01711749, was titled 'Rosuvastatin Calcium Bioequivalence Study - Fast', indicating that Crestor refers to this form of the drug.