Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Met DR · 1 trial · 1 indication
AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration after the standardized dinner. Doses were administered 1 min prior to 0 h (standardized dinner) for once daily in the evening (qPM) and twice daily (BID) dosing and 1 min prior to 12 h (standardized breakfast) for once daily in the morning (qAM) and BID dosing.
Cmax = Maximum concentration from the first dose of study medication administration (0 h) to the time of the last quantifiable concentration following dose administration. Doses were administered 1 min prior to 0 h (standardized dinner) for qPM and BID dosing and 1 min prior to 12 h (standardized breakfast) for qAM and BID dosing.
| Arm | Type | Description |
|---|---|---|
| 500 mg Met DR BID | EXPERIMENTAL | Two doses of 500 mg metformin delayed-release |
| 1000 mg Met DR BID | EXPERIMENTAL | Two doses of 1000 mg metformin delayed-release |
| 1000 mg Met IR BID | ACTIVE_COMPARATOR | Two doses of 1000 mg metformin immediate-release |
| 2000 mg Met XR QD | ACTIVE_COMPARATOR | Single dose of 2000 mg metformin extended-release |
| Name | Type | Description |
|---|---|---|
| Met DR | DRUG | metformin delayed-release tablets |
| Met XR | DRUG | metformin extended-release tablets |
| Met IR | DRUG | metformin immediate-release tablets |
Inclusion Criteria: 1. 19 to 65 (inclusive) years old at Visit 1 (Screening) 2. Male, or if female and met all of the following criteria: 1. Not breastfeeding 2. Negative pregnancy test result at Visit 1 (Screening) (not applicable to hysterectomized females) 3. Surgically sterile, postme...
Met DR is an investigational small molecule being studied in healthy subjects. It is currently in Phase 1 clinical development, with a completed trial assessing its pharmacokinetics compared to other metformin formulations. It has not been approved by the FDA and remains in clinical investigation.
Met DR is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The company is conducting clinical research on this investigational drug, which is currently in Phase 1 development for use in healthy subjects.
Met DR is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It is not FDA approved and is still undergoing clinical evaluation to assess its safety and pharmacokinetics in healthy subjects.
Met DR has one completed clinical trial, NCT02291510, titled 'Assessing the PK of Met DR, Met IR, and Met XR in Healthy Subjects.' This Phase 1 study enrolled 20 healthy volunteers and was active-controlled, though it was not double-blinded. The trial is now complete.
Met DR is a distinct formulation being studied alongside Met IR and Met XR in a pharmacokinetic trial. While all are metformin-based, Met DR is specifically evaluated for its own release profile. The trial compares these formulations to understand their differences in healthy subjects.