Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects
NCT05166096 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-06-14
Summary
The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally.
Conditions
- Healthy
Interventions
- DRUG
-
Rho-11
Subjects will be administered 325 mg aspirin by rapid IV push
- DRUG
-
aspirin 325mg
Subjects will be administered 325 mg aspirin orally
Sponsors & Collaborators
-
Rhoshan Pharmaceuticals Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-03
- Primary Completion
- 2022-05-11
- Completion
- 2022-05-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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