Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trospium Chloride · 1 trial · 1 indication
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...
Trospium Chloride is an investigational small molecule being studied in healthy subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety and tolerability when administered alone or with metformin hydrochloride.
Trospium Chloride is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
Trospium Chloride is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA, and is being studied for safety and tolerability in healthy volunteers.
Trospium Chloride has one completed Phase 1 trial, NCT00986401, titled 'Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects.' The trial enrolled 44 participants in the United States and was a randomized, controlled study.
Trospium Chloride is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with one completed trial in healthy subjects. No approval status has been established.