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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00986401 | Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects | PHASE1 | COMPLETED | 44 | — | — | Oct 1, 2009 | Nov 1, 2009 | Dec 19, 2011 | 1 | United States |
Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood.
| Arm | Type | Description |
|---|---|---|
| Glucophage® then Sanctura XR® (AB) | EXPERIMENTAL | Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days. |
| Sanctura XR® then Glucophage® (BA) | EXPERIMENTAL | Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days. |
| Name | Type | Description |
|---|---|---|
| Trospium Chloride (Sanctura XR®) | DRUG | extended release, 60 mg, oral daily |
| Metformin hydrochloride (Glucophage®) | DRUG | immediate release, 500mg |
Inclusion Criteria: * Weight within +/-30% of ideal body weight for height and frame size * Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 1 months prior to the screening visit). * Willing to abstain from caffeine-containing food and beverages...