Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast.
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. Sixteen healthy, non-smoking, non-obese, male and female volunteers between 18-55 years of age will be randomly assigned in a crossover fashion to receive each of two dosing regimens in sequence with a 14 day washout period between dosing periods. In each of the dosing periods, after an overnight fast, subjects will receive one intact Colcrys® 0.6 mg tablet (followed by 240 mL of water) or one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice (followed by 220 mL of water) according to the randomization schedule. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose at times sufficient to adequately define the pharmacokinetics of colchicine. Vital signs (blood pressure, heart rate, respiratory rate, and temperature) will be measured prior to dosing and at 1 hour ± 30 minutes post dose. Subjects will be monitored throughout their participation in the study for adverse reactions.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colcrys® (colchicine USP) 0.6 mg intact tablet | Experimental | One Colcrys® (colchicine USP) 0.6 mg intact tablet taken by mouth |
|
| Colcrys® 0.6 mg tab in apple juice | Experimental | One Colcrys® 0.6 mg tablet crushed and dissolved in apple juice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colchicine 0.6 mg tablet | Drug | One Colcrys® 0.6 mg intact tablet taken by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | The maximum or peak concentration that Colcrys® reaches in the plasma | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC (0-t)] | The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration |
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant. | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Darin B Brimhall, D.O. | Novum Pharmaceutical Research Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novum Pharmaceutical Research Services | Las Vegas | Nevada | 89121 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Colcrys® Intact Tab Then Colcrys® Dissolved in Apple Juice | On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice, after an overnight fast of at least 10 hours |
| FG001 | Colcrys® Dissolved in Apple Juice Then Colcrys® Intact Tab | On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and dissolved in 20 mL of apple juice after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Washout Period of 14 Days |
| |||||||||||||
| Period 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Colcrys® Intact Tab and Colcrys® Dissolved in Apple Juice | All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours. |
| 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 | Maximum Plasma Concentration (Cmax) | The maximum or peak concentration that Colcrys® reaches in the plasma | Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons. | Posted | Mean | Standard Deviation | ng/mL | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration |
|
Not provided
One participant withdrew from the study after receiving the the test formulation (Colcrys® 0.6 mg tablet crushed and dissolved in apple juice) in Period 1.
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 | Colcrys® 0.6 mg Tablet Administered Intact | All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache ∗ | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Mutual Pharmaceutical Company, Inc. | 215-697-1743 | clinicaltrials@urlmutual.com |
Not provided
| ID | Term |
|---|---|
| D003078 | Colchicine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| colchicine 0.6 mg tablet | Drug | One Colcrys® 0.6 mg tablet dissolved in apple juice |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours |
|
|
| Primary | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC (0-t)] | The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule | Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons. | Posted | Mean | Standard Deviation | ng-hr/mL | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration |
|
|
|
| Primary | Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant. | Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons. | Posted | Mean | Standard Deviation | ng-hr/mL | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice | All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours. | 0 | 16 | 1 | 16 |
| Increased Blood Pressure | Investigations | Non-systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
Not provided