Clinical Trial Details
| Trial ID: | L6508 |
| Source ID: | NCT05081583 |
| Associated Drug: | Midazolam Hcl 1mg/Ml Inj |
| Title: | Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT05081583/results |
| Conditions: | Interaction, Adverse Herb-Drug|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Midazolam Hcl 1Mg/Ml Inj|DIETARY_SUPPLEMENT: Goldenseal (Hydrastis canadensis) |
| Outcome Measures: | Primary: Metformin AUC, Area under the plasma concentration time curve of metformin, Before and 20 minutes, 40 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, and 12 hours after midazolam administration.|Metformin Cmax, maximum concentration of metformin, Before and 20 minutes, 40 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, and 12 hours after midazolam administration. | Secondary: Metformin Half-Life, half-life of metformin, 0-24h|Metformin Renal Clearance, renal clearance of metformin, 0-24h|Midazolam AUC, area under the concentration vs. time curve of midazolam, Before and 20 minutes, 40 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, and 12 hours after midazolam administration. |
| Sponsor/Collaborators: | Sponsor: Washington State University | Collaborators: National Center for Complementary and Integrative Health (NCCIH) |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | EARLY_PHASE1 |
| Enrollment: | 22 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2021-09-16 |
| Completion Date: | 2023-08-31 |
| Results First Posted: | 2024-12-19 |
| Last Update Posted: | 2024-12-19 |
| Locations: | Washington State University College of Pharmacy and Pharmaceutical Sciences, Spokane, Washington, 99202, United States |
| URL: | https://clinicaltrials.gov/show/NCT05081583 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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