Clinical TrialID 2389
Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product
NCT05158192
Bioequivalence
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Trial: 1Ingredient: 1Links: 1
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2389
- Evidence Id
- 2389
- Core Evidence Id
- 2389
- Source Clinical Trial Id
- 2366
- Herb2 Clinical Trial Id
- HBCT002366
- Nct Id
- NCT05158192
- Title
- Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Bioequivalence
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: Diosmin/Hesperidin (90/10) 500 mg Test Drug|DRUG: Diosmin/Hesperidin (90/10) 500 mg Reference Product
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Intervention Purpose
- Basic_Science
- Gender
- All
- Age
- Adult
- Enrollment
- 12
- Outcome Measure
- Total Diosmin/Hesperidin (90/10): area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72), 23 samples up to 72 hours will be taken after the administration in each period., From tablet intake and up to 72 hours after tablet intake|Total Diosmin/Hesperidin (90/10): area under the plasma concentration-time curve from 0 to t hours (AUC0-t), 23 samples up to 72 hours will be taken after the administration in each period., From tablet intake and up to 72 hours after tablet intake|Total Diosmin/Hesperidin (90/10): Maximum plasma concentration (Cmax), 23 samples up to 72 hours will be taken after the administration in each period., From tablet intake and up to 72 hours after tablet intake
- Sponsor Collaborator
- Laboratorios Andromaco S.A.
- Funded By
- INDUSTRY
- Location
- Azidus Laboratories Ltd., Chennai, Tamil Nadu, 600048, India
- Other Id
- HP8834-01
- Start Date
- 2021-11-04
- Primary Completion Date
- 2021-12-14
- Completion Date
- 2021-12-14
- First Posted
- 2021-12-15
- Results First Posted
- Last Update Posted
- 2022-02-14
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05158192
- Title Cn
- Title En
- Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product
- Bilingual Status
- semi_complete