Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT01354418
First received: May 13, 2011
Last updated: July 28, 2011
Last verified: July 2011
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Purpose
This study will assess the food-effect bioavailability of an extended release formulation of phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl product.
| Condition | Intervention | Phase |
|---|---|---|
|
Nasal Congestion |
Drug: Phenylephrine HCl Extended Release Drug: Phenylephrine HCl Immediate Release |
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: | A Randomized Crossover Bioequivalence Study Comparing a Single Dose of Phenylephrine HCl 30 mg Extended Release Tablet to Three Phenylephrine HCl 10 mg Immediate Release Tablets Each Consecutively Dosed Four Hours Apart Under Fed and Fasting Conditions |
Resource links provided by NLM:
Drug Information available for:
Phenylephrine
Phenylephrine hydrochloride
Oxymetazoline
Oxymetazoline hydrochloride
U.S. FDA Resources
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Maximum plasma concentration (Cmax) of phenylephrine [ Time Frame: 0 hours to time of maximum observed plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) ] [ Designated as safety issue: No ]
- Time to Cmax (Tmax) of phenylephrine [ Time Frame: 0 hours to time of maximum observed plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) ] [ Designated as safety issue: No ]
- Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC[0-t]) [ Time Frame: 0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) ] [ Designated as safety issue: No ]
- Area under the concentration versus time curve from time 0 to infinity (AUC[0-∞]) [ Time Frame: 0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) ] [ Designated as safety issue: No ]
- Terminal rate constant (λz) [ Time Frame: 0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) ] [ Designated as safety issue: No ]
- Terminal elimination half-life (t1/2) [ Time Frame: 0 hours to t1/2 of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | May 2011 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Drug: Phenylephrine HCl Extended Release
One phenylephrine HCl 30 mg extended release tablet orally
|
|
Experimental: 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
|
Drug: Phenylephrine HCl Extended Release
One phenylephrine HCl 30 mg extended release tablet orally
|
|
Active Comparator: 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
|
Drug: Phenylephrine HCl Immediate Release
One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
|
|
Active Comparator: 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
|
Drug: Phenylephrine HCl Immediate Release
One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- In good health
- 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 significant medical condition which is a contraindication to the use of phenylephrine HCl, might interfere with the study, or requires treatment expected to affect blood pressure
- 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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01354418 History of Changes |
| Other Study ID Numbers: | P08340, CL2010-18 |
| Study First Received: | May 13, 2011 |
| Last Updated: | July 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Phenylephrine Oxymetazoline Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Cardiotonic Agents |
Cardiovascular Agents Therapeutic Uses Mydriatics Autonomic Agents Peripheral Nervous System Agents Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013