Clinical TrialID 5660
A Food-Drug Interaction Study of Serum Urate After Oral Inosine
NCT02614469
Healthy
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5660
- Evidence Id
- 5660
- Core Evidence Id
- 5660
- Source Clinical Trial Id
- 5646
- Herb2 Clinical Trial Id
- HBCT005646
- Nct Id
- NCT02614469
- Title
- A Food-Drug Interaction Study of Serum Urate After Oral Inosine
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Healthy
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Inosine
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- Male
- Age
- Adult, Older_Adult
- Enrollment
- 18
- Outcome Measure
- Cmax: Maximum Observed Serum Urate Concentration, -12 to 0 hrs pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post-dose|AUC (0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Plasma Concentration), -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|AUC (0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity, -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|Tmax: Time of Maximum Serum Concentration, -12 to 0 hr pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|T1/2: Apparent Terminal Half-life, -12 to 0 pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|Baseline Corrected Cmax: Baseline Corrected Maximum Serum Concentration, Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero., -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|Baseline Corrected AUC (0-t): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Serum Concentration), Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero., -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|Baseline Corrected AUC (0-inf): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity, Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2)., -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose|Baseline Corrected Tmax: Baseline Corrected Time of Maximum Serum Concentration, Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2)., -12 to 0 h pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose|Baseline Corrected T1/2: Baseline Corrected Apparent Terminal Half-life, Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2)., -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose
- Sponsor Collaborator
- Michael Alan Schwarzschild|Michael J. Fox Foundation for Parkinson's Research|The Parkinson Alliance
- Funded By
- OTHER
- Location
- Covance Clinical Research Unit Inc., Evansville, Indiana, 47710, United States
- Other Id
- INO-PD-P3-2015-FE
- Start Date
- 2015-03
- Primary Completion Date
- 2016-04
- Completion Date
- 2016-05
- First Posted
- 2015-11-25
- Results First Posted
- 2017-02-24
- Last Update Posted
- 2017-03-29
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02614469
- Title Cn
- Title En
- A Food-Drug Interaction Study of Serum Urate After Oral Inosine
- Bilingual Status
- semi_complete