Study Completed

Pain

Bayer Identifier:

16645

ClinicalTrials.gov Identifier:

NCT03056703

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

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

Trial Dates

February 2014 - March 2014

Phase

Phase 1

Could I Receive a placebo

Products

Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Hackensack, 07601, United States

Primary Outcome

AUC0-inf (area under plasma concentration versus time curve) for ASA (acetylsalicylic acid)
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No
AUC0-t for ASA
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No
Cmax (maximum plasma concentration) for ASA
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No

Secondary Outcome

AUC0-inf for SA (salicylic acid)
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No
AUC0-t for SA
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No
Cmax for SA
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No
t1/2 for ASA and SA
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No
tmax for ASA and SA
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No
Lambda(z) (terminal rate constant) for ASA and SA
Time Frame:
baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Safety Issue:
No

Trial design

An Open Label, Randomized, Two-Way Crossover Trial to assess the Bioequivalence of a single oral dose of a 1000 mg Fast Release Aspirin Tablet versus Two 500 mg Fast Release Aspirin Tablets in healthy male and female subjects

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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