Clinical TrialID 805
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
NCT00984009
Pharmacokinetics
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 805
- Evidence Id
- 805
- Core Evidence Id
- 805
- Source Clinical Trial Id
- 788
- Herb2 Clinical Trial Id
- HBCT000788
- Nct Id
- NCT00984009
- Title
- A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Pharmacokinetics
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: Colchicine|OTHER: Grapefruit Juice|DRUG: Colchicine
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Basic_Science
- Gender
- All
- Age
- Adult
- Enrollment
- 24
- Outcome Measure
- Maximum Plasma Concentration (Cmax), The maximum or peak concentration that colchicine reaches in the plasma., serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose 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 colchicine concentration (t), as calculated by the linear trapezoidal rule., serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose 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 colchicine plasma concentration to the elimination rate constant., serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration
- Sponsor Collaborator
- Mutual Pharmaceutical Company, Inc.
- Funded By
- INDUSTRY
- Location
- PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, 58104, United States
- Other Id
- MPC-004-08-1017
- Start Date
- 2008-09
- Primary Completion Date
- 2008-10
- Completion Date
- 2008-10
- First Posted
- 2009-09-24
- Results First Posted
- 2009-09-24
- Last Update Posted
- 2011-11-21
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00984009
- Title Cn
- Title En
- A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
- Bilingual Status
- semi_complete