Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04640571
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2020-11-09
Brief Title:
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study employs two-sub-studies that share a common placebo arm
The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics We hypothesize that metformin represses the bile salt export pump BSEP in the liver which excretes pravastatin and chenodeoxycholic acid from the liver into the bile
The objective of the other sub-study is to assess the impact of polysorbate 80 on valacyclovir chenodeoxycholic acid and enalaprilat pharmacokinetics We hypothesize that polysorbate 80 inhibits uptake transporters in the intestine which absorb valacyclovir and chenodeoxycholic acid in the gut via the peptide transporter 1 PepT1 and apical sodium-bile acid transporter ASBT respectively Enalaprilat is passively absorbed but with low permeability and thus serves as a passive absorption reference
The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics We hypothesize that metformin represses the bile salt export pump BSEP in the liver which excretes pravastatin and chenodeoxycholic acid from the liver into the bile
The objective of the other sub-study is to assess the impact of polysorbate 80 on valacyclovir chenodeoxycholic acid and enalaprilat pharmacokinetics We hypothesize that polysorbate 80 inhibits uptake transporters in the intestine which absorb valacyclovir and chenodeoxycholic acid in the gut via the peptide transporter 1 PepT1 and apical sodium-bile acid transporter ASBT respectively Enalaprilat is passively absorbed but with low permeability and thus serves as a passive absorption reference
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None