Pharmacokinetic Study Comparing Aspirin and Aspirin Granules
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01072604
First received: February 19, 2010
Last updated: April 21, 2013
Last verified: April 2013
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Purpose
To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects
| Condition | Intervention | Phase |
|---|---|---|
|
Pharmacokinetics |
Drug: Acetylsalicylic acid (Aspirin, BAY1019036) Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Aspirin Tablets and Aspirin Dry Granules in Healthy Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess safety and tolerability of the new aspirin formula [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- To assess additional pharmacokinetic parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | July 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
One oral dose of new formula Aspirin Prototype 1 under fasting conditions
|
| Experimental: Arm 2 |
Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
One oral dose of new formula Aspirin Prototype 2 under fasting conditions
|
| Active Comparator: Arm 3 |
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
One oral dose of Aspirin Plain Tablet under fasting conditions
|
| Active Comparator: Arm 4 |
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
One oral dose of Aspirin Dry Granules under fasting conditions
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female subjects between 18 to 55 years of age inclusive with a 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 range 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, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
- Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol
Exclusion Criteria:
- History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products
- Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing
- Syndromes of asthma, rhinitis or nasal polyps
- Females who are pregnant or lactating
- Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
- Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical and Medical Affairs, Bayer Consumer Care Inc. |
| ClinicalTrials.gov Identifier: | NCT01072604 History of Changes |
| Other Study ID Numbers: | 14558 |
| Study First Received: | February 19, 2010 |
| Last Updated: | April 21, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Bayer:
|
Aspirin Acetylsalicylic Acid |
Additional relevant MeSH terms:
|
Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013