Class 3 Biowaivers
Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: cimetidine (or acyclovir) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of Maryland Official(s) and/or principal investigator(s): James Polli, Principal Investigator, Affiliation: University of Maryland
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 (e. g. tablets,capsules). 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 (i. e. 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.
Clinical Details
Official title: Evaluation of Biopharmaceutics Classification System Class 3 Drugs for Possible Biowaivers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Change in the amount of drug in blood during the study
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or Female
- Age 18-55
- Healthy volunteers: Subjects in good health, as determined by screening evaluation
that is not greater than 30 days before the first drug study visit
- Willing to avoid caffeine containing products 24 hours prior to and day of study
visits
- Willing to stop all OTC medications for 24 hours prior to and during study visits
- Able to provide informed consent
Exclusion Criteria:
- Presence of significant medical disease (including cardiovascular, pulmonary,
hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric)
- Presence of hepatic, renal disease
- Pregnant women, breast feeding or trying to become pregnant
- Excessive alcohol use (i. e. current physical, behavioral, or personal manifestations
related to the abuse or dependency on alcohol)
- Routine use (i. e. daily or weekly) prescription medication except birth control pills
- Routine use (i. e. daily or weekly) use of acid blockers, antacids, anti-diarrhea,
stimulants, appetite suppressants, or anti nausea medication or other drugs that
modulate GI function
- Currently taking cimetidine (or acyclovir) or medication known to interact with
cimetidine (or acyclovir)
- Allergic to cimetidine (or acyclovir)
- Undergoing therapy for solid tumor or blood malignancy
- Any condition in which in the opinion of the PI or medical physician would increase
risk to the subject or interfere with the integrity of the study.
Locations and Contacts
University of Maryland, Baltimore, Maryland 21201, United States
Additional Information
Starting date: June 2009
Last updated: November 21, 2013
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