Therapeutic EquivalencePhase 1Morpheus PKNCT01666678
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
A Phase 1 study testing BAY98-7111, Naproxen Sodium (Aleve, BAYH6689) and Diphenhydramine HCl in people with Therapeutic Equivalence, run by Bayer at 1 site in United States.
Trial summary
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets)… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Therapeutic Equivalence
- What is being tested?
- BAY98-7111, Naproxen Sodium (Aleve, BAYH6689) and Diphenhydramine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2012
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Health, ambulatory male and female subjects between 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 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
Who cannot join
- History of hypersensitivity to aspirin (ASA), naproxen sodium, NSAIDs, acetaminophen, DPH HCL, and similar pharmacological agents or components of the products
- History of hypersensitivity to any of the food products in the standardized breakfast or cannot consume all food/beverage items contained in the standardized breakfast
- Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the Dosing Periods, other than trial treatment
- Use of any over-the-counter or prescription medications (except acceptable forms of birth control) within 10 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject
- Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or 1-2 weeks after treatment
- Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)
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- History of gastrointestinal bleeding or perforation, related to previous NSAID therapy or active or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
- Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
- Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bioavailability Study of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Under Fasting and Fed Conditions
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
- Conditions
- Therapeutic Equivalence
- Being tested
- BAY98-7111, Naproxen Sodium (Aleve, BAYH6689), Diphenhydramine HCl
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY98-7111Drug
2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions
Naproxen Sodium (Aleve, BAYH6689)Drug
2 x Naproxen Sodium 220 mg under fasting conditions
Diphenhydramine HClDrug
2 x Diphenhydramine HCl 25 mg under fasting conditions
BAY98-7111Drug
2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY98-7111 |
| Arm 2 | Active comparator | Not described Receives: Drug: Naproxen Sodium (Aleve, BAYH6689) |
| Arm 3 | Active comparator | Not described Receives: Drug: Diphenhydramine HCl |
| Arm 4 | Experimental | Not described Receives: Drug: BAY98-7111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodium
Measured: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of DPH HCL(Diphenhydramine Hydrochloride)
Measured: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Cmax(Maximum drug concentration) in plasma of naproxen sodium
Measured: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Cmax(Maximum drug concentration) in plasma of DPH HCL(Diphenhydramine Hydrochloride)
Measured: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalenceStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666678
- Sponsor's protocol ID
- 16135
- Acronym
- Morpheus PK
- Status last verified
- Aug 2014
- First submitted
- 14 Aug 2012
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioavailability Study of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT01666678
- Acronym / sponsor ID
- Morpheus PK / 16135
- Conditions
- Therapeutic Equivalence
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Aug 2012 (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.
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY98-7111 |
| Arm 2 | Active comparator | Drug: Naproxen Sodium (Aleve, BAYH6689) |
| Arm 3 | Active comparator | Drug: Diphenhydramine HCl |
| Arm 4 | Experimental | Drug: BAY98-7111 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Health, ambulatory male and female subjects between 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 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
Key exclusion criteria (10 listed)
- History of hypersensitivity to aspirin (ASA), naproxen sodium, NSAIDs, acetaminophen, DPH HCL, and similar pharmacological agents or components of the products
- History of hypersensitivity to any of the food products in the standardized breakfast or cannot consume all food/beverage items contained in the standardized breakfast
- Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the Dosing Periods, other than trial treatment
- Use of any over-the-counter or prescription medications (except acceptable forms of birth control) within 10 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject
- Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or 1-2 weeks after treatment
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 |
|---|---|---|
| BAY98-71112 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions | Drug | Arm 1 |
| Naproxen Sodium (Aleve, BAYH6689)2 x Naproxen Sodium 220 mg under fasting conditions | Drug | Arm 2 |
| Diphenhydramine HCl2 x Diphenhydramine HCl 25 mg under fasting conditions | Drug | Arm 3 |
| BAY98-71112 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions | Drug | Arm 4 |
Primary outcome
AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodium
Time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of DPH HCL(Diphenhydramine Hydrochloride)
Time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Cmax(Maximum drug concentration) in plasma of naproxen sodium
Time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Cmax(Maximum drug concentration) in plasma of DPH HCL(Diphenhydramine Hydrochloride)
Time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: up to 6 weeks
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 21 Aug 2014.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY98-7111, Naproxen Sodium (Aleve, BAYH6689) and Diphenhydramine HCl in people with Therapeutic Equivalence, run by Bayer at 1 site in United States.
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 10 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 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodium (time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing). The study lists 4 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 21 Aug 2014.