Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients

Phase < 1

Waitlist Available

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-24 hours

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial studies how goldenseal supplements affect the diabetes medication metformin in adults with type 2 diabetes. It aims to see if goldenseal changes how metformin is absorbed and processed, which could help create guidelines for using natural products with medications. Metformin is a commonly prescribed drug used primarily for managing type II diabetes.

Eligible Conditions

Type 2 Diabetes
Diabetes
Herb-Drug Interactions

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Metformin area under the concentration vs. time curve (AUC) ratio (exposure/baseline)

Secondary study objectives

Metformin Cmax ratio (exposure/baseline)

Metformin half-life ratio (exposure/baseline)

Midazolam Cmax ratio (exposure/baseline)

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Study Arm 3: Chronic Goldenseal ExposureExperimental Treatment2 Interventions

For Arm 3, the same 20 subjects will be administered goldenseal (1.1 g) orally three times daily for 27 days. On the 28th day, participants will be administered the goldenseal three times daily, as well as the single dose of midazolam (as described in Arm 1). Plasma and urine will be collected in a manner identical to that in Arm 1. A designated washout period for midazolam will not be necessary to separate Arm 3 from Arm 2 since there will be 27 days of goldenseal administration prior to the midazolam administration.

Group II: Study Arm 2: Acute Goldenseal ExposureExperimental Treatment2 Interventions

For Arm 2, the same 20 subjects will be administered a single dose of goldenseal (3.3 g) orally 30 minutes prior to administration of midazolam (as described in Arm 1). Plasma and urine will be collected in a manner identical to that in Arm 1. With respect to midazolam administration, a washout period of 7 days will separate Arm 2 from Arm 1.

Group III: Study Arm 1: BaselineExperimental Treatment1 Intervention

Twenty type 2 diabetic subjects (10 men, 10 women) will be administered a single dose of midazolam (0.5 mg) intravenously via a peripherally inserted catheter in conjunction with their daily oral administration of metformin. Plasma and urine will be collected from 0-24 hours post-midazolam administration. Participants will take their metformin as prescribed for the entirety of the study with no interruption in pharmacotherapy.

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