Ignite Creation Date:
2025-12-18 @ 9:32 AM
Ignite Modification Date:
2025-12-23 @ 9:48 PM
Study NCT ID:
NCT02743247
Status:
None
Last Update Posted:
2016-04-19 00:00:00
First Post:
2015-12-18 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults
Sponsor:
None
Organization:
Study Overview
Official Title:
Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults
Status:
None
Status Verified Date:
2016-04
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:
Study consists of three periods with fixed sequence: 1) single dose of mycophenolate mofetil 1,000mg; 2) single dose of tacrolimus 5mg; 3) single dose of mycophenolate mofetil 1,000mg and tacrolimus 5mg. All subjects have one week of washing period between single dose administration. Blood samples are drawn up to 72 hours after drug administration. Single nucleotide polymorphisms known to result in pharmacokinetic variability of study drug are also investigated. Drug interaction is going to be assessed through the ratio of area under the concentration curve of one drug in the presence or absence of another drug.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: