Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
Кључне речи
Апстрактан
Опис
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 sprinkled on applesauce (1 tablespoon) 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 sprinkled on 1 tablespoon of applesauce (followed by 240 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, 1 hour ± 30 minutes post-dose and upon discharge from the clinical facility. Subjects will be monitored throughout their participation in the study for adverse reactions.
Датуми
| Последња верификација: | 04/30/2011 |
| Фирст Субмиттед: | 05/20/2010 |
| Предвиђена пријава послата: | 05/23/2010 |
| Прво објављено: | 05/24/2010 |
| Послато последње ажурирање: | 05/09/2011 |
| Последње ажурирање објављено: | 05/11/2011 |
| Датум првог достављања резултата: | 04/04/2011 |
| Датум првог подношења резултата КЦ: | 04/04/2011 |
| Датум првог објављивања резултата: | 05/10/2011 |
| Стварни датум почетка студије: | 04/30/2010 |
| Процењени датум примарног завршетка: | 05/31/2010 |
| Предвиђени датум завршетка студије: | 05/31/2010 |
Стање или болест
Интервенција / лечење
Drug: Colcrys® 0.6 mg intact tablet
Drug: Colcrys® 0.6 mg tablet on applesauce
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Experimental: Colcrys® 0.6 mg intact tablet One Colcrys® 0.6 mg intact tablet taken by mouth | Drug: Colcrys® 0.6 mg intact tablet One Colcrys® 0.6 mg intact tablet taken by mouth |
| Experimental: Colcrys® 0.6 mg tablet on applesauce One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce | Drug: Colcrys® 0.6 mg tablet on applesauce One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: - Healthy adults age 18-55, non-smoking, non- pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index of 18-30 kg/m² Exclusion Criteria: - Recent participation (within 30 days) in other research studies - Recent significant blood donation or plasma donation - Pregnant or lactating - Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) - History of treatment for drug or alcohol addiction within the previous 12 months or use of tobacco products within 90 days of the start of the study - Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic disorders, diabetes or bleeding disorders, gastrointestinal disease or history of malabsorption within the last year - History of psychiatric disorders occurring within the last two years that required hospitalization or medication - Presence of a medical condition requiring regular treatment with prescription drugs - Use of any drugs or substances known to inhibit or induce drug-metabolizing enzymes within 30 days prior to dosing with the study drug - Drug allergies or sensitivity to colchicine - Positive test results for drugs of abuse at screening |
Исход
Примарне мере исхода
1. Maximum Plasma Concentration (Cmax) [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]
2. Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [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]
3. Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] [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]
