Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01711749 | Rosuvastatin Calcium Bioequivalence Study - Fast | PHASE1 | COMPLETED | 60 | — | — | Feb 25, 2013 | Mar 13, 2013 | Jun 20, 2017 | 1 | Brazil |
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 ...