To Evaluate the Bioavailability of a Single Oral Dose of the Acetylsalicylic Acid Containing Dry Powder 500 mg in Comparison to the Bioavailability of a Single Oral Dose of Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adults.
Status: | Completed |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/21/2016 |
Start Date: | February 2015 |
End Date: | March 2015 |
An Open Label Crossover Pharmacokinetic Trial of Aspirin Dry Powder Versus Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adult Subjects
To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing
dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin
tablets and aspirin effervescent tablets in healthy adults.
dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin
tablets and aspirin effervescent tablets in healthy adults.
Inclusion Criteria:
- Healthy ,male and female subjects 18 to 55 years of age, inclusive
- Body Mass Index (BMI) of approximately 18 to 30 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.
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 1,2 and
3
- Females who are pregnant or lactating
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