- Natural product: Goldenseal (Hydrastis canadensis)
- Associated study: R21 Goldenseal Project
In Vivo Interaction Study
Oral Metformin/Oral Inhibitor Mouse Study - (-)-β-hydrastine
No Effect (based on bioequivalence limits) was detected.
Results
Control:
-AUC0-4h: 4.7 (24)
-AUCR (ratio of AUC0-4h in presence of test article to vehicle; values represented as geometric means with 90% CI): N/A
-AUCR (ratio of AUC0-12h in presence of test article to vehicle; values represented as geometric means with 90% CI): N/A
Test:
-AUC0-4h: 4.4 (21)
-AUCR (ratio of AUC0-4h in presence of test article to vehicle; values represented as geometric means with 90% CI): 0.93 (0.82-1.07)
-AUCR (ratio of AUC0-12h in presence of test article to vehicle; values represented as geometric means with 90% CI): 0.95 (0.82-1.11)
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|---|---|---|---|---|---|
| metformin | 7.2 (20)µmol/L*h | AUC(0-t) Mean (CV%) (geometric) | Test | Total collection time: 12 hours | null | |
| metformin | 7.6 (22)µmol/L*h | AUC(0-t) Mean (CV%) (geometric) | Control | Total collection time: 12 hours | null | |
| metformin | -5.26% | AUC(0-t) Change from control | P-value: Not significant | |||
| metformin | 1.4 (23)µmol/L | Cmax Mean (CV%) (geometric) | Test | null | ||
| metformin | 1.6 (21)µmol/L | Cmax Mean (CV%) (geometric) | Control | null | ||
| metformin | -12.50% | Cmax Change from control | P-value: Not significant | |||
| metformin | 2 (22)h | Half-life (terminal) Mean (CV%) (geometric) | Test | null | ||
| metformin | 2 (10)h | Half-life (terminal) Mean (CV%) (geometric) | Control | null | ||
| metformin | 0% | Half-life (terminal) Change from control | P-value: Not significant | |||
| metformin | 2 (1.0 - 4.0)h | Tmax Median (range) | Test | null | ||
| metformin | 1.5 (1.0 - 2.0)h | Tmax Median (range) | Control | null | ||
| metformin | 33.33% | Tmax Change from control | P-value: Not significant |
Experimental Conditions
Blood was used for LC-MS analysis.
Single dosing
Males
FVB
8 per test group
The form has been tweaked for the mice study.
Study population: mice
Study population phenotype: Jackson laboratory (Bar Harbor, Maine)
0.25, 0.5, 1, 2, 4, 8, and 12 h
None
Drug or Natural Product Administration
Oral
Liquid
Metformin (10 mg/kg)
Single dose administered by oral gavage at 10 ml/kg for both goldenseal and other test articles.
Once
Oral
N/A
(–)-β-Hydrastine (46 mg/kg)
Single dose administered by oral gavage at 10 ml/kg for both goldenseal and other test articles.
Once
Goldenseal
Yes - sent to Clarke lab by Dr. Oberlies at UNCG
N/A
Pharmacodynamics (PD) & Adverse Events
N/A
N/A
N/A