Clinical TrialID 3723

Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate

NCT02171624

Healthy

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
3723
Evidence Id
3723
Core Evidence Id
3723
Source Clinical Trial Id
3696
Herb2 Clinical Trial Id
HBCT003696
Nct Id
NCT02171624
Title
Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate
Status
Completed
Phase
Phase 1
Study Result
No
Study Condition
Healthy
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Intervention
DRUG: dabigatran etexilate|DRUG: quinidine
Intervention Allocation
Randomized
Intervention Model
Crossover
Intervention Mask
Intervention Purpose
Treatment
Gender
All
Age
Adult
Enrollment
42
Outcome Measure
Differences between treatments in systolic blood pressure profiles (using area under the BP-time curve), -0:15 before, and every 15 minutes for 2 hours post-dose, 3, 4 and 12 hours post dose|Incidence of symptomatic hypotension, -0:15 before, and every 15 minutes for 2 hours post-dose, 3, 4 and 12 hours post dose
Sponsor Collaborator
Boehringer Ingelheim
Funded By
INDUSTRY
Location
Other Id
1160.9
Start Date
2009-03
Primary Completion Date
2009-04
Completion Date
First Posted
2014-06-24
Results First Posted
Last Update Posted
2014-06-24
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02171624
Title Cn
Title En
Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate
Bilingual Status
semi_complete