Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
NCT ID: NCT01354418
Last Updated: 2015-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2011-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Phenylephrine HCl Extended Release - Fasted
Single dose phenylephrine HCl extended release tablet administered under fasted conditions on Day 1 in one of four study periods
Phenylephrine HCl Extended Release
One phenylephrine HCl 30 mg extended release tablet orally
Phenylephrine HCl Extended Release - Fed
Single dose phenylephrine HCl extended release tablet administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods
Phenylephrine HCl Extended Release
One phenylephrine HCl 30 mg extended release tablet orally
Phenylephrine HCl Immediate Release - Fasted
Three single doses of phenylephrine HCl immediate release tablet four hours apart, with the first dose administered under fasted conditions on Day 1 in one of four study periods
Phenylephrine HCl Immediate Release
One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
Phenylephrine HCl Immediate Release - Fed
Three single doses of phenylephrine HCl immediate release tablet four hours apart, with the first dose administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods
Phenylephrine HCl Immediate Release
One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
Interventions
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Phenylephrine HCl Extended Release
One phenylephrine HCl 30 mg extended release tablet orally
Phenylephrine HCl Immediate Release
One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
Eligibility Criteria
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Inclusion Criteria
* Female participants must not be pregnant
* Agrees to use two acceptable methods of birth control throughout the study
* Agrees not to take monoamine oxidase inhibitor (MAOI) for 2 weeks prior to, during, and 2 weeks after the end of the study
Exclusion Criteria
* Any infectious disease within 4 weeks prior to initial treatment administration
* History of malignancy, except basal cell carcinoma
* Cannot comply with requirement to abstain from the use of any drugs (except acetaminophen or herbal/vitamin supplements) within 14 days prior to study and alcohol or xanthine-containing substances (coffee, chocolate) within 72 hours prior to study
* Received an investigational drug within thirty days prior to study drug dosing
* Known or apparent current or former drug addicts or alcoholics
* Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B surface antigen, or hepatitis C antibody
* Cannot accept a high-fat, high-calorie breakfast
* Known allergy or intolerance to phenylephrine HCl
* Have used phenylephrine-containing product within 2 weeks prior to study start
* Have smoked tobacco, used tobacco products, or used a nicotine-containing smoking cessation aid within the past 6 months
18 Years
45 Years
ALL
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Other Identifiers
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CL2010-18
Identifier Type: OTHER
Identifier Source: secondary_id
P08340
Identifier Type: OTHER
Identifier Source: secondary_id
18124
Identifier Type: -
Identifier Source: org_study_id
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