Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets

Pain Clinical Trial

— Mille  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056703
• Other study ID #: 16645
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2017
• Last updated: February 15, 2017
• Start date: February 2014
• Est. completion date: March 2014

Study information

• Verified date: February 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Acetylsalicylic acid (Aspirin, BAY1019036)
One Fast Release Tablet containing 1000 mg acetylsalicylic acid
• Acetylsalicylic acid (Aspirin, BAY1019036)
Two Fast Release Tablets containing 500 mg acetylsalicylic acid each

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-inf (area under plasma concentration versus time curve) for ASA (acetylsalicylic acid)		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
Primary	AUC0-t for ASA		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
Primary	Cmax (maximum plasma concentration) for ASA		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
Secondary	AUC0-inf for SA (salicylic acid)		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
Secondary	AUC0-t for SA		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
Secondary	Cmax for SA		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
Secondary	t1/2 for ASA and SA		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
Secondary	tmax for ASA and SA		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
Secondary	Lambda(z) (terminal rate constant) for ASA and SA		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

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