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COMPLETED
NCT05166096
PHASE1

Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects

Sponsor: Rhoshan Pharmaceuticals Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally.

Official title: A Phase 1, Open-Label, 2-Period, 2-Formulation, Within-Subject Crossover Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects Under Fasting Conditions

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2021-12-03

Completion Date

2022-05-11

Last Updated

2026-08-12

Healthy Volunteers

Yes

Conditions

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

Locations (1)

PPD Early Development

Austin, Texas, United States