Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01256879
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2010-11-15
Brief Title:
Cimetidine Biowaivers
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of Excipient Effects on Biopharmaceuticals Classification System BCS Class 3 Drug Cimetidine
Status:
COMPLETED
Status Verified Date:
2019-08
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 purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed This is called bioequivalence Medications taken by mouth such as capsules and solutions need to be absorbed into the body in order to do any good Capsules and solutions contain a drug but also contain non-drug ingredients that are called excipients or fillers Excipients in the capsules and solutions can impact how much drug is absorbed into the body This is called bioINequivalence Capsules and solutions in this research contain the drug cimetidine This drug is being used since it has high water solubility can dissolve in water and low ability to be absorbed
Detailed Description:
The investigators anticipate that common excipients do not cause bioINequivalence 1 The hypothesize is that commonly used excipients in oral medications change the rate or extent of Class 3 drug absorption and result in bioINequivalence 2 Alternative hypothesis is that commonly used excipients in oral medications do not change the rate or extent of Class 3 drug absorption and do not result in bioINequivalence
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSF2232000910020C | OTHER_GRANT | HHSF2232000910020C | None |