Trial Condition(s):

Pain

Bioequivalence of single dose fast release aspirin (1000 mg) tablet versus single dose of two 500 mg fast release aspirin tablets (Mille)

Bayer Identifier:

16645

ClinicalTrials.gov Identifier:

NCT03056703

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The primary objective of this study is to compare the bioavailability of a single dose of a new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a commercially available 500 mg fast release tablet and to test for bioequivalence of the new versus the commercial product in healthy adult subjects.

Inclusion Criteria
- Healthy ambulatory male and female subjects 18 to 55 years of age, inclusive
 - Body Mass Index (BMI) of approximately 18.5 to 30.0 kg/m2, and a total body weight >50 kg (110 lbs)
 - Results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the Principal Investigator or Sponsor
 - Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
 - Provide a personally signed and dated informed consent prior to inclusion in the trial indicating that the subject has been informed of all pertinent aspects of the trial.
Exclusion Criteria
- History of hypersensitivity to acetylsalicylic acid (ASA), naproxen sodium, acetaminophen, other non-steroidal anti-inflammatory drugs (NSAIDs), and similar pharmacological agents or components of the products
 - History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy.  Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
 - Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) seven days prior to dosing or during the Treatment Periods, other than study product
 - Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
 - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular,  hepatic, psychiatric, neurologic disease, or malignancies
 - Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1 or 2
 - Females who are pregnant or lactating
 - Consumption of xanthine-containing food and beverages within 24 h before investigational medicinal product (IMP) administration during Treatment Periods 1 and 2; or not willing to abstain from any xanthine containing food and beverages during the study

Trial Summary

Enrollment Goal
38
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Hackensack, United States, 07601

Status
Completed
 

Trial Design