Goldenseal (Hydrastis canadensis)
A clinical study of transporter-mediated goldenseal drug interactions
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Effects of the goldenseal product on the efflux transporter breast cancer resistance protein (BCRP) and uptake transporters organic anion transporting polypeptide (OATP) 1B1/3, as well as organic anion transporters (OATs), organic cation transporters (OCTs), multidrug and toxin extrusion proteins (MATEs), and CYP3A, were next evaluated in 16 healthy volunteers using a cocktail approach.
1 . clinical goldenseal - midazolam experiment (id=NPDI-DboNmw)
Results
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Probe cocktail study
Fixed-sequence
Healthy volunteers
16
8 male and 8 female (non-lactating women )
24, 48, 72, and 96 hours after cocktail administration
Drug or Natural Product Administration
Oral
Furosemide (10 mg/mL solution; West-ward Pharmaceuticals Corp., Eatontown, NJ), metformin (500 mg/5 mL solution; Ranbaxy Pharmaceuticals, Inc., Jacksonville, FL), rosuvastatin (10 mg tablet; Camber Pharmaceuticals Inc., Piscataway, NJ), and midazolam (2 mg/mL syrup; West-ward Pharmaceuticals Corp.)
1 mg furosemide, 50 mg metformin, 10 mg rosuvastatin, and 2.5 mg midazolam
single dose
once
Oral
capsule
3 g
1 g every 4 hours
3 times
Now Foods, Bloomingdale, IL
2019
2 . clinical goldenseal - furosemide experiment (id=NPDI-bcNEPw)
In Vivo Interaction Study
No Effect (based on bioequivalence limits) was detected.
- OAT1 (SLC22A6)
- OAT3 (SLC22A8)
Results
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Probe cocktail study
Fixed-sequence
Healthy volunteers
16
8 male and 8 female (non-lactating women )
24, 48, 72, and 96 hours after cocktail administration
Drug or Natural Product Administration
Oral
Furosemide (10 mg/mL solution; West-ward Pharmaceuticals Corp., Eatontown, NJ), metformin (500 mg/5 mL solution; Ranbaxy Pharmaceuticals, Inc., Jacksonville, FL), rosuvastatin (10 mg tablet; Camber Pharmaceuticals Inc., Piscataway, NJ), and midazolam (2 mg/mL syrup; West-ward Pharmaceuticals Corp.)
1 mg furosemide, 50 mg metformin, 10 mg rosuvastatin, and 2.5 mg midazolam
single dose
once
Oral
capsule
3 g
1 g every 4 hours
3 times
Now Foods, Bloomingdale, IL
2019
3 . clinical goldenseal - rosuvastatin acid experiment (id=NPDI-8KuZrA)
In Vivo Interaction Study
No Effect (based on bioequivalence limits) was detected.
rosuvastatin 1510813
- BCRP (ABCG2)
- OATP1B1 (SLCO1B1)
- OATP1B3 (SLCO1B3)
Results
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Probe cocktail study
Fixed-sequence
Healthy volunteers
16
8 male and 8 female (non-lactating women )
24, 48, 72, and 96 hours after cocktail administration
Drug or Natural Product Administration
Oral
Furosemide (10 mg/mL solution; West-ward Pharmaceuticals Corp., Eatontown, NJ), metformin (500 mg/5 mL solution; Ranbaxy Pharmaceuticals, Inc., Jacksonville, FL), rosuvastatin (10 mg tablet; Camber Pharmaceuticals Inc., Piscataway, NJ), and midazolam (2 mg/mL syrup; West-ward Pharmaceuticals Corp.)
1 mg furosemide, 50 mg metformin, 10 mg rosuvastatin, and 2.5 mg midazolam
single dose
once
Oral
capsule
3 g
1 g every 4 hours
3 times
Now Foods, Bloomingdale, IL
2019
4 . clinical goldenseal - rosuvastatin lactone experiment (id=NPDI-M015vQ)
In Vivo Interaction Study
No Effect (based on bioequivalence limits) was detected.
- OATP1B1 (SLCO1B1)
- OATP1B3 (SLCO1B3)
Results
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Probe cocktail study
Fixed-sequence
Healthy volunteers
16
8 male and 8 female (non-lactating women )
24, 48, 72, and 96 hours after cocktail administration
Drug or Natural Product Administration
Oral
Furosemide (10 mg/mL solution; West-ward Pharmaceuticals Corp., Eatontown, NJ), metformin (500 mg/5 mL solution; Ranbaxy Pharmaceuticals, Inc., Jacksonville, FL), rosuvastatin (10 mg tablet; Camber Pharmaceuticals Inc., Piscataway, NJ), and midazolam (2 mg/mL syrup; West-ward Pharmaceuticals Corp.)
1 mg furosemide, 50 mg metformin, 10 mg rosuvastatin, and 2.5 mg midazolam
single dose
once
Oral
capsule
3 g
1 g every 4 hours
3 times
Now Foods, Bloomingdale, IL
2019
5 . clinical goldenseal - metformin study (id=NPDI-_zSDOQ)
In Vivo Interaction Study
Decreased systemic exposure was detected.
metformin 1503297
- MATE1 (SLC47A1)
- MATE2-K (SLC47A2)
- OCT1 (SLC22A1)
- OCT2 (SLC22A2)
Results
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Probe cocktail study
Fixed-sequence
Healthy volunteers
16
8 male and 8 female (non-lactating women )
24, 48, 72, and 96 hours after cocktail administration
Drug or Natural Product Administration
Oral
Furosemide (10 mg/mL solution; West-ward Pharmaceuticals Corp., Eatontown, NJ), metformin (500 mg/5 mL solution; Ranbaxy Pharmaceuticals, Inc., Jacksonville, FL), rosuvastatin (10 mg tablet; Camber Pharmaceuticals Inc., Piscataway, NJ), and midazolam (2 mg/mL syrup; West-ward Pharmaceuticals Corp.)
1 mg furosemide, 50 mg metformin, 10 mg rosuvastatin, and 2.5 mg midazolam
single dose
once
Oral
capsule
3 g
1 g every 4 hours
3 times
Now Foods, Bloomingdale, IL
2019