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Nonsteroidal Anti-inflammatory Drug

Oral aspirin administered in Period 1, Rho-11 administered in Period 2 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Rhoshan Pharmaceuticals Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing.
Awards & highlights

Study Summary

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in serum thromboxane B2 from baseline
Secondary outcome measures
Acetylsalicylic Acid Plasma Pharmacokinetics
Salicylic Acid Plasma Pharmacokinetics
Urinary 11-dehydro-TXB2 levels
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Rho-11 administered in Period 1, oral aspirin administered in Period 2Experimental Treatment2 Interventions
Group II: Oral aspirin administered in Period 1, Rho-11 administered in Period 2Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rho-11
2021
Completed Phase 1
~30
aspirin 325mg
2021
Completed Phase 1
~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Rhoshan Pharmaceuticals IncLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
PPD Early Development
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects
2021. "Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05166096.
~7 spots leftby Apr 2025
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