← Back to Search

Arm 1: I-ASA 100mg, then C-ASA 162mg tablet for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Vectura, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexually active female subjects of childbearing potential must be willing to use an acceptable contraceptive method throughout the study as defined in the protocol.
Male or female, ≥18 and ≤55 years of age, with BMI >18.5 and <32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440
Awards & highlights

Study Summary

This trial will compare two aspirin treatments to measure safety, effectiveness & how they are absorbed.

Eligible Conditions
  • Healthy Subjects

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum thromboxane B2 (TxB2) serum concentration - Area under the effect curve (AUEC) of the % Change from baseline (CFB) in serum TxB2 concentration (TxB2 suppression)
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC0-inf)
Area under the plasma concentration versus time curve (AUC0-t)
Incidence and frequency of Adverse Events.
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: C-ASA 162mg tablet, then I-ASA 100mgExperimental Treatment2 Interventions
Treatment A: Single dose of 162 mg chewable non-enteric-coated Aspirin (C-ASA). Treatment B: Single dose of 100 mg ASA powder for oral inhalation (I-ASA) via DPI.
Group II: Arm 1: I-ASA 100mg, then C-ASA 162mg tabletExperimental Treatment2 Interventions
Treatment A: Single dose of 100 mg ASA powder for oral inhalation (I-ASA) via DPI. Treatment B: Single dose of 162 mg chewable non-enteric-coated Aspirin (C-ASA).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASA
2010
Completed Phase 3
~4480
non-enteric-coated chewable aspirin
2022
Completed Phase 1
~90

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vectura, Inc.Lead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
Syneos HealthOTHER
172 Previous Clinical Trials
68,380 Total Patients Enrolled

Frequently Asked Questions

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

Has the Food and Drug Administration cleared Arm 2: C-ASA 162mg tablet, then I-ASA 100mg for public use?

"Taking into account the Phase 1 status of Arm 2: C-ASA 162mg tablet, then I-ASA 100mg, our team at Power judged its safety to be a 1 due to sparse evidence in favour of efficacy and safety."

Answered by AI

Are there any specific eligibility requirements for participants in this trial?

"To qualify, applicants must meet the criteria of healthy subjects and be between 18-55 years old. This trial is currently seeking 88 participants in total."

Answered by AI

How many participants are currently included in this clinical experiment?

"Accurate. Clinicaltrials.gov reveals that this medical experiment, which posted on October 14th 2022, is still recruiting patients. Currently 88 individuals are required to participate at 2 locations worldwide."

Answered by AI

Does this research trial include minors under the age of 18?

"The age limits for this medical trial are 18 and 55 respectively, as stated by the inclusion criteria."

Answered by AI

Is this experiment currently in search of participants?

"Affirmative. The clinicaltrials.gov website reveals that this experiment, which was first announced on October 14th 2022, is actively recruiting subjects. About 88 people are expected to participate at 2 test centres."

Answered by AI
~36 spots leftby Mar 2025