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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00468897 | A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites. | PHASE1 | COMPLETED | 50 | — | — | Mar 21, 2007 | May 2, 2007 | Aug 7, 2017 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Treatment Arm AB | EXPERIMENTAL | A will be a single tablet RSG XR 8 milligram (mg) manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm AB subject will receive A regimen in Period 1 and B regimen in Period 2.There will be wash-out period of 5 days between doses. |
| Treatment Arm BA | EXPERIMENTAL | A will be a single tablet RSG XR 8 mg manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm BA subject will receive B regimen in Period 1 and A regimen in Period 2. There will be wash-out period of 5 days between doses. |
| Name | Type | Description |
|---|---|---|
| RSG XR | DRUG | RSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water. |
Inclusion Criteria: * Healthy male or female aged 18-55 years. * BMI between 19 - 30 kg/m2 Exclusion criteria: * Liver function tests above the upper limit * Excessive alcohol consumption history * History of Cigarette smoking * Positive HIV, Hep B or C test * Positive pregnancy test * History of...