Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01010698
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2009-11-09
Brief Title:
Class 3 Biowaivers
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of Biopharmaceutics Classification System Class 3 Drugs for Possible Biowaivers
Status:
COMPLETED
Status Verified Date:
2020-11
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 Biopharmaceutics Classification System BCS is employed by the US FDA to categorize drug substances into 4 classes and to characterize drugs in terms of aqueous solubility and intestinal permeability The four BCS categories for a drug substance are Class 1 Class 2 Class 3 and Class 4 Biopharmaceutical properties of aqueous solubility and intestinal permeability with drug product dissolution determine the rate and extent of drug absorption from immediate-release IR and solid oral dosages forms eg tabletscapsules Each class exhibits information regarding biopharmaceutic properties and bioequivalence For example Class 1 drugs have the most favorable oral biopharmaceutic properties high solubility and high permeability With these biopharmaceutic properties for class 1 drugs results in vivo bioequivalence BE studies for rapidly dissolving IR solid oral dosage forms the FDA provided waivers This approach alone has resulted in new and generic drugs approved based on vitro data alone ie biowaived with great savings in resources and reduction in unnecessary human testing
Objectives 1 The primary objective of this study is to assess whether common excipients cause bioinequivalence of Class 3 drugs 2 The secondary objective is the results of the study will contribute towards providing scientific evidence to the FDA for consideration of Class 3 drugs for BCS-based biowaivers
Hypotheses The investigators anticipate that common excipients do not cause bioinequivalence 1 Hence the hypothesize of this study is commonly used excipients in oral medications tablets capsules modulate the rate or extent of Class 3 drug absorption and result in bioinequivalence 2 Alternative hypothesis is that commonly used excipients in oral medications tablets capsules do not modulate the rate or extent of Class 3 drug absorption and do not result in bioinequivalence
Objectives 1 The primary objective of this study is to assess whether common excipients cause bioinequivalence of Class 3 drugs 2 The secondary objective is the results of the study will contribute towards providing scientific evidence to the FDA for consideration of Class 3 drugs for BCS-based biowaivers
Hypotheses The investigators anticipate that common excipients do not cause bioinequivalence 1 Hence the hypothesize of this study is commonly used excipients in oral medications tablets capsules modulate the rate or extent of Class 3 drug absorption and result in bioinequivalence 2 Alternative hypothesis is that commonly used excipients in oral medications tablets capsules do not modulate the rate or extent of Class 3 drug absorption and do not result in bioinequivalence
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSF223200810041C | OTHER_GRANT | Food and Drug Administration | None |