Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HHSF2232000910020C | Other Grant/Funding Number | HHSF2232000910020C |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CimTest-A | Experimental | 200mg cimetidine (as 2 capsules) |
|
| CimTest-B | Experimental | 200mg cimetidine (as 2 capsules) |
|
| Sorbitol-free cimetidine solution | Active Comparator | 200mg cimetidine (as oral liquid) |
|
| Commercial cimetidine solution | Experimental | 200mg cimetidine (as oral liquid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: cimetidine | Drug | cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | pharmacokinetic exposure (ng*hr/ml) | 0-10 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Polli, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11745735 | Background | Rege BD, Yu LX, Hussain AS, Polli JE. Effect of common excipients on Caco-2 transport of low-permeability drugs. J Pharm Sci. 2001 Nov;90(11):1776-86. doi: 10.1002/jps.1127. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cimetidine | cimetidine 200mg total dose (single dose) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
healthy subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cimetidine | cimetidine 200mg total dose (single dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC | pharmacokinetic exposure (ng*hr/ml) | Posted | Mean | Standard Error | ng*hr/ml | 0-10 hours |
|
10 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: CimTest-A | cimetidine capsule with hydroxypropyl methylcellulose (HPMC), a type of filler cimetidine: cimetidine 200mg total dose (single dose) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | pain at IV site |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Polli, Professor | U of Maryland | 410-706-8292 | jpolli@rx.umaryland.edu |
Not provided
| ID | Term |
|---|---|
| D002927 | Cimetidine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
non-commercial cimetidine solution
cimetidine: cimetidine 200mg total dose (single dose)
| OG003 | Experimental: Commercial Cimetidine Solution | commercial cimetidine solution cimetidine: cimetidine 200mg total dose (single dose) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | Experimental: CimTest-B | cimetidine capsule with magnesium stearate, a type of filler cimetidine: cimetidine 200mg total dose (single dose) | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Active Comparator: Sorbitol-free Cimetidine Solution | non-commercial cimetidine solution cimetidine: cimetidine 200mg total dose (single dose) | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Experimental: Commercial Cimetidine Solution | commercial cimetidine solution cimetidine: cimetidine 200mg total dose (single dose) | 0 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided
Not provided
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |