Interaction Between St John's Wort and Metformin?
|ClinicalTrials.gov Identifier: NCT01726764|
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Depression||Other: St John's Wort Drug: Metformin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Is There a Pharmacokinetic Interaction Between St John's Wort and Metformin?|
|Study Start Date :||January 2013|
|Primary Completion Date :||June 2013|
|Study Completion Date :||May 2014|
7 days of pretreatment with metformin before full pharmacokinetics and other goals are investigated.
Minimum 1 week of washout after this period. 3 weeks of pretreatment with St John's Wort and the last 7 days metformin is ingested again, and the same effect parameters as described above is performed again
|Other: St John's Wort Drug: Metformin|
- Change in Area Under Curve (AUC) 0-24h of metformin [ Time Frame: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion ]Change in 0-24h AUC of metformin after 3 weeks of treatment with St John's Wort
- Oral glucose tolerance test (OGTT) [ Time Frame: During the first 2 hours of each metformin ingestion ]Changes in: Plasma-glucose, serum-insulin, glucagon-like peptide 1 (GLP-1) and connecting-peptides (C-peptides) during the oral glucose tolerance test, measured at 0, 0.5, 1, 1.5 and 2 hours after metformin ingestion.
- Pharmacokinetics of metformin [ Time Frame: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion, which will be used to determine the pharmacokinetic parameters mentioned below ]Determination of other pharmacokinetic parameters of metformin such as clearance (CL), absorption fraction (F), distribution volume (V), the minimum concentration at steady state (Css,min), elimination half life (T 1/2) etc.
- Change in messenger RiboNucleic Acid (mRNA) [ Time Frame: Will be measured 4 times: At inclusion (t=0 on that day), at t=0 in both periods and minimum 3 weeks after finalization of the study (t=0 on that day) ]Changes in mRNA encoding OCT1 will be measured at 4 different time points to give an insight to the importance of St John's Wort effect on the OCT1 production
- Hypericin/hyperforin [ Time Frame: At t=0 in 2nd period ]If possible measure the concentrations of some of the active components of St John's Wort, hypericin and hyperforin
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726764
|Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark|
|Odense, Denmark, DK-5000|
|Principal Investigator:||Per Damkier, MD ph.d.||University of Southern Denmark|
|Principal Investigator:||Tore B. Stage, M.Sc. Pharm||University of Southern Denmark|
|Study Director:||Kim Brøsen, Professor, MD||University of Southern Denmark|