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HealthyPhase 1NCT07323680

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

A Phase 1 study testing 325 mg Oral Aspirin and 325 mg aspirin by rapid IV push in people with Healthy, run by Rhoshan Pharmaceuticals Inc at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
325 mg Oral Aspirin and 325 mg aspirin by rapid IV push
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCzechia
Study dates
15 Jun 2025to 12 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Each subject must meet all of the following criteria to be enrolled in this study:
  • Healthy males and non-pregnant and no breast-feeding females, ≥ 18 and ≤ 55 years of age (on the day of Informed Consent).
  • Non-smokers or past smokers (having ceased smoking at least 6 months before the first dosing).
  • Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 on the day of screening.
  • The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at Screening.
  • The subject has a hemoglobin level with the following acceptable range at Screening: (Male: 12.8 to 17.4 g/dL (128 to 174 g/L); Female: 10.8 to 15.0 g/dL (108 to 150 g/L).
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  • The subject has liver function tests within normal limits or has results that do not show clinically significant abnormalities, as judged by the investigator at Screening.
  • The subject has estimated glomerular filtration rate eGFR (CKD-EPI) ≥50 mL/min (0.833mL/sec/1.73m2) at Screening.
  • Acceptance of use of contraceptive measures during the whole study by both female and male subjects.
  • No tattoo, body piercing or any cosmetic treatment involving skin penetration within 90 days before screening, unless evaluated by Investigator as non-significant for inclusion in the study.
  • The subject agrees to comply with all protocol requirements.
  • The subject can provide written informed consent.
  • The subject must fluently speak and understand Czech.

Who cannot join

  • Subjects meeting any of the following criteria will be excluded from the study:
  • The subjects has had any major illness within 3 months before dosing with study drug or any significant ongoing chronic medical illness, as judged by the investigator.
  • The subjects has a history of active deep vein thrombosis and/or thromboembolic disorder, including history of hypothrombinemia and vitamin K deficiency.
  • The subject has a history of neuropsychiatric disease, hypertension, cardiac failure, cerebrovascular disease, chronic respiratory disease, asthma, nasal polyps associated with asthma, hepatic or renal impairment, recent dehydration (within last 30 days), gout thyrotoxicosis or systemic lupus erythematosus and other connective tissue disorders.
  • The subject has a history of gastrointestinal bleeding or has active gastrointestinal disease that could affect drug absorption.
  • The subject has a history of hemorrhagic disorder.
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  • Prothrombin time or activated partial thromboplastin time level outside the normal range at screening and check-in.
  • The subject has an increased risk of bleeding including but not limited to: any history of a clinically significant bleeding problem, any recent (within 30 days preceding the first dose of study drug) major trauma, platelet count <100,000 mm3
  • The subject has a history of glucose-6-phosphate dehydrogenase deficiency.
  • The subject has a recent history of tooth extraction within 3 weeks before dosing with study drug.
  • The subject is a smoker or has used nicotine-containing products (e.g., snuff, nicotine patch, nicotine chewing gum, mock cigarettes, inhalers, or "vape" devices) within 6 months before the first dose of study drug and throughout the study (including the washout period).
  • The subject has a history of alcohol abuse or drug addiction within 1 year prior to check-in or excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects), or use of alcohol 48 hours before dosing with study drug.
  • The subject has a positive test result for drugs of abuse, alcohol, or cotinine at screening or before dosing with study drug.
  • The subject has used any prescription (excluding hormonal birth control) or over-the-counter medications, including fish oil and other herbal or nutritional supplements and, in particular, aspirin (no aspirin-containing medications allowed at all), nonsteroidal anti-inflammatory agents (No NSAIDS allowed at all, and no acetaminophen, diclofenac, ketorolac allowed), or anticoagulation therapy within 14 days before dosing with study drug and throughout the entire study period (including the washout period).
  • The subject has received vaccination against Varicella zoster within 6 weeks before dosing with study drug.
  • The subject has a positive test result for COVID-19, hepatitis B surface antigen, hepatitis C virus antibody, or HIV type 1 or 2 antibodies at screening.
  • The subject has received the COVID-19 vaccine within 14 days before Day -3, or subjects who plan to receive a COVID-19 vaccine at any time during the study.
  • The subject has a history of relevant drug and/or food allergies (i.e., allergy to aspirin or any excipients, allergic skin reactions, or any significant food allergy that could preclude a standard diet in the clinical unit).
  • The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (e.g. marmalade), or alcohol-, caffeine-, poppy-, or xanthine-containing products within 48 hours.
  • The subject is involved in strenuous activity or contact sports within 24 hours before dosing with study drug and during the study.
  • The subject has donated blood or blood products >450 mL within 30 days before dosing with study drug.
  • The subject has received study drug in another investigational study within 30 days or 5 half-lives, whichever is longer, before dosing with study drug.
  • In the opinion of the investigator, the subject is not suitable for entry into the study.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Quinta-Analytica s.r.o.

    Prague

Other trials in Czechia

About this study

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.

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

Conditions
Healthy
Being tested
325 mg Oral Aspirin, 325 mg aspirin by rapid IV push

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 325 mg Oral AspirinDrug

    Drug: aspirin 325mg

    • Subjects will be administered 325 mg aspirin orally

  • 325 mg aspirin by rapid IV pushDrug

    Also called Rho-11

    Drug: Rho-11 Subjects will be administered 325 mg aspirin by rapid IV push

Study groups in NCT07323680
Study groupRoleWhat they receive
Rho-11 administered in Period 1, oral aspirin administered in Period 2ExperimentalNot described
Receives: Drug: 325 mg Oral Aspirin; Drug: 325 mg aspirin by rapid IV push
Oral aspirin administered in Period 1, Rho-11 administered in Period 2ExperimentalNot described
Receives: Drug: 325 mg Oral Aspirin; Drug: 325 mg aspirin by rapid IV push

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum thromboxane B2 from baseline

    Change in serum thromboxane B2 from baseline to 180 minutes post treatment

    Measured: 1 hour before dosing and 2, 5, 10, 20, 30, 45, 60, and 180 minutes post dosing]

Secondary outcomes (4)

  1. Urinary 11-dehydro-TXB2 levels

    Measured levels of 11-dehydro-TXB2 in urine following treatment

    Measured: Every 12 hours from 24 hours prior to dosing to 72 hours after dosing.

  2. Urinary 2,3-dinor-6-keto-PGF1alpha

    Measured levels of 2,3-dinor-6-keto-PGF1alpha in urine following treatment

    Measured: Every 12 hours from 24 hours prior to dosing to 72 hours after dosing.

  3. Acetylsalicylic Acid Plasma Pharmacokinetics

    Measured change in levels of acetylsalicylic acid in plasma following treatment

    Measured: 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 postdosing.

  4. Salicylic Acid Plasma Pharmacokinetics

    Measured change in levels of salicylic acid in plasma following treatment

    Measured: 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 postdosing.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start15 Jun 2025
  3. Primary completion7 Jul 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07323680
Sponsor's protocol ID
Rho-11-003
Status last verified
Jun 2026
First submitted
18 Dec 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 325 mg Oral Aspirin and 325 mg aspirin by rapid IV push in people with Healthy, run by Rhoshan Pharmaceuticals Inc at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum thromboxane B2 from baseline (time frame: 1 hour before dosing and 2, 5, 10, 20, 30, 45, 60, and 180 minutes post dosing]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07323680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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