Nasal CongestionPhase 1NCT01354418
Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
A Phase 1 study testing Phenylephrine HCl Extended Release and Phenylephrine HCl Immediate Release in people with Nasal Congestion, run by Bayer.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Phenylephrine HCl Extended Release and Phenylephrine HCl Immediate Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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
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.
- Conditions
- Nasal Congestion
- Being tested
- Phenylephrine HCl Extended Release, Phenylephrine HCl Immediate Release
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine HCl Extended ReleaseDrug
One phenylephrine HCl 30 mg extended release tablet orally
Phenylephrine HCl Immediate ReleaseDrug
One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine HCl Extended Release - Fasted | Experimental | Single dose phenylephrine HCl extended release tablet administered under fasted conditions on Day 1 in one of four study periods Receives: Drug: Phenylephrine HCl Extended Release |
| Phenylephrine HCl Extended Release - Fed | Experimental | Single dose phenylephrine HCl extended release tablet administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods Receives: Drug: Phenylephrine HCl Extended Release |
| Phenylephrine HCl Immediate Release - Fasted | Active comparator | 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 Receives: Drug: Phenylephrine HCl Immediate Release |
| Phenylephrine HCl Immediate Release - Fed | Active comparator | 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 Receives: Drug: Phenylephrine HCl Immediate Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of phenylephrine
Measured: 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)
Time to Cmax (Tmax) of phenylephrine
Measured: 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)
Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC[0-t])
Measured: 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)
Area under the concentration versus time curve from time 0 to infinity (AUC[0-∞])
Measured: 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)
Terminal rate constant (λz)
Measured: 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)
Terminal elimination half-life (t1/2)
Measured: 0 hours to t1/2 of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354418
- Sponsor's protocol ID
- 18124
- Other IDs
- CL2010-18, P08340
- Status last verified
- Feb 2015
- First submitted
- 13 May 2011
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01354418
- Acronym / sponsor ID
- 18124
- Conditions
- Nasal Congestion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine HCl Extended Release - Fasted | Experimental | Drug: Phenylephrine HCl Extended ReleaseSingle dose phenylephrine HCl extended release tablet administered under fasted conditions on Day 1 in one of four study periods |
| Phenylephrine HCl Extended Release - Fed | Experimental | Drug: Phenylephrine HCl Extended ReleaseSingle 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 Immediate Release - Fasted | Active comparator | Drug: Phenylephrine HCl Immediate ReleaseThree 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 - Fed | Active comparator | Drug: Phenylephrine HCl Immediate ReleaseThree 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrine HCl Extended ReleaseOne phenylephrine HCl 30 mg extended release tablet orally | Drug | Phenylephrine HCl Extended Release - Fasted, Phenylephrine HCl Extended Release - Fed |
| Phenylephrine HCl Immediate ReleaseOne phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses | Drug | Phenylephrine HCl Immediate Release - Fasted, Phenylephrine HCl Immediate Release - Fed |
Primary outcome
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phenylephrine HCl Extended Release and Phenylephrine HCl Immediate Release in people with Nasal Congestion, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.