HealthyPhase 1NCT03184766
Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study
A Phase 1 study testing Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets and Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules in people with Healthy, run by Reckitt Benckiser Healthcare (UK) Limited.
Trial summary
This comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen \& 30 mg pseudoephedrine). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets and Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2016to 30 Jan 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects who have given written informed consent.
- Age: ≥ 18 years ≤ 50 years.
- Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m2.
- Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception unless of non-childbearing potential or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
- Female subject of non-child bearing potential with negative pregnancy test at the screening visit.
- Male subject willing to use an effective method of contraception unless anatomically sterile or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
Who cannot join
- Pregnant or lactating females.
- A history and/or presence of significant disease of any body system, including psychiatric disorders.
- Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
- A history of allergy or intolerance related to treatment with ibuprofen, aspirin, other NSAIDs, pseudoephedrine, other sympathomimetic or catecholamine derivative decongestant drugs or the excipients of the formulations.
- A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
- A history of hypertension or hypertension that is currently treated with antihypertensive medication.
Show all 25Show fewer
- A history of frequent dyspepsia, e.g. heartburn or indigestion.
- A history of migraine.
- Current smokers and ex-smokers who have smoked or used nicotine replacement products during the previous 6 months prior to first dosing.
- A history of substance abuse (including alcohol).
- High consumption of stimulating drinks (coffee, tea, cola, energy drinks etc.; total caffeine intake per day above 300 mg).
- Those with positive screen/test for drugs of abuse and alcohol.
- Those with a positive screen for ibuprofen.
- Ingestion of a prescribed drug at any time in the 14 days before the first dose of study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers 30 days prior to the first dose of study medication.
- Ingestion of an over-the-counter preparation within 7 days before the first dose of study medication, including herbal medications, vitamin/fish oil supplements, ibuprofen, other NSAIDs or decongestants.
- Donation of blood in quantity > 400 ml e.g. to the blood transfusion service in the 12 weeks prior to the first dose of study medication
- Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
- Topical use of ibuprofen within 7 days before the first dose of study medication.
- Those previously randomised into this study.
- Those who are an employee at the study site.
- Those who are a partner or first degree relative of the Investigator.
- Those who have participated in a clinical trial in the 12 weeks prior to the first dose of study medication.
- Those unable in the opinion of the Investigator to comply fully with the study requirements.
- Those who have consumed grapefruit or grapefruit juice, pummelo or Seville oranges in the 7 days prior to randomisation.
- Those who are unwilling to consume gelatine of animal origin.
About this study
Official title: An Open-label, Randomised, Three-way Cross-over, Single Dose, Single Centre, Comparative Pharmacokinetic Study Between Ibuprofen and Pseudoephedrine Liquid Capsules (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Test), Ibuprofen and Pseudoephedrine Tablets (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Comparator 1), and Ibuprofen Liquid Capsules (2x 200 mg Solubilised Ibuprofen) (Comparator 2)
This comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen \& 30 mg pseudoephedrine).
- Conditions
- Healthy
- Being tested
- Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets, Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsulesDrug
2 x 200 mg ibuprofen \& 30 mg pseudoephedrine
Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tabletsDrug
2 x 200 mg ibuprofen \& 30 mg pseudoephedrine
Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsulesDrug
2 x 200 mg solubilised ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment Order: Test, Comparator 1, Comparator 2 Receives: Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules |
| 2 | Experimental | Treatment Order: Test, Comparator 2, Comparator 1 Receives: Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules |
| 3 | Experimental | Treatment Order: Comparator 1, Test, Comparator 2 Receives: Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules |
| 4 | Experimental | Treatment Order: Comparator 1, Comparator 2, Test Receives: Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules |
| 5 | Experimental | Treatment Order: Comparator 2, Test, Comparator 1 Receives: Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules |
| 6 | Experimental | Treatment Order: Comparator 2, Comparator 1, Test Receives: Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pseudoephedrine AUC0-t for Test vs. Comparator 1.
The Test and Comparator 1 will be considered similar if for pseudoephedrine, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis: 0-48hrs
Pseudoephedrine Cmax for Test vs. Comparator 1.
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis: 0-48hrs
Ibuprofen AUC0-t for Test vs. Comparator 2.
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis: 0-48hrs
Ibuprofen Cmax for Test vs. Comparator 2.
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis: 0-48hrs
Secondary outcomes (10)
Ibuprofen AUC0-t for Test vs. Comparator 1.
The Test and Comparator 1 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
- Cmax for ibuprofen (in the context of the Test vs. Comparator 1 comparison)
Measured: PK Analysis: 0-48hrs
Ibuprofen Cmax for Test vs. Comparator 1.
The Test and Comparator 1 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Measured: PK Analysis: 0-48hrs
Assessment of how fast the ibuprofen from the Test product starts to be absorbed and how quickly it reaches the therapeutic level.
T8.4 - time to reach the therapeutic level (8.4 µg/ml) for ibuprofen.
Measured: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Cn - the plasma concentration of an active at each planned nominal time-point.
Measured: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
AUC0-inf - Area under the plasma concentration-time curve from administration to infinity.
Measured: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
administration to infinity. AUCR - ratio AUC0-t / AUC0-inf.
Measured: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Tmax -Time until Cmax is first achieved.
Measured: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Kel - elimination rate constant.
Measured: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
T1/2 - plasma concentration half-life.
Measured: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Tlag - time between administration and the beginning of absorption of ibuprofen. This will be calculated only for the Test.
Measured: PK Analysis: 0-48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start10 Aug 2016
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Robert Adams, MBBS, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184766
- Sponsor's protocol ID
- NL1309
- Status last verified
- Apr 2017
- First submitted
- 17 May 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Three-way Cross-over, Single Dose, Single Centre, Comparative Pharmacokinetic Study Between Ibuprofen and Pseudoephedrine Liquid Capsules (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Test), Ibuprofen and Pseudoephedrine Tablets (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Comparator 1), and Ibuprofen Liquid Capsules (2x 200 mg Solubilised Ibuprofen) (Comparator 2)
- ClinicalTrials.gov ID
- NCT03184766
- Acronym / sponsor ID
- NL1309
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- 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 comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen \& 30 mg pseudoephedrine).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets, Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsulesTreatment Order: Test, Comparator 1, Comparator 2 |
| 2 | Experimental | Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets, Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsulesTreatment Order: Test, Comparator 2, Comparator 1 |
| 3 | Experimental | Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets, Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsulesTreatment Order: Comparator 1, Test, Comparator 2 |
| 4 | Experimental | Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets, Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsulesTreatment Order: Comparator 1, Comparator 2, Test |
| 5 | Experimental | Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets, Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsulesTreatment Order: Comparator 2, Test, Comparator 1 |
| 6 | Experimental | Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets, Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsulesTreatment Order: Comparator 2, Comparator 1, Test |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female subjects who have given written informed consent.
- Age: ≥ 18 years ≤ 50 years.
- Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m2.
- Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception unless of non-childbearing potential or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
Key exclusion criteria (25 listed)
- Pregnant or lactating females.
- A history and/or presence of significant disease of any body system, including psychiatric disorders.
- Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
- A history of allergy or intolerance related to treatment with ibuprofen, aspirin, other NSAIDs, pseudoephedrine, other sympathomimetic or catecholamine derivative decongestant drugs or the excipients of the formulations.
- A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
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 |
|---|---|---|
| Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules2 x 200 mg ibuprofen \& 30 mg pseudoephedrine | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets2 x 200 mg ibuprofen \& 30 mg pseudoephedrine | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules2 x 200 mg solubilised ibuprofen | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Pseudoephedrine AUC0-t for Test vs. Comparator 1.
Time frame: PK Analysis: 0-48hrs
The Test and Comparator 1 will be considered similar if for pseudoephedrine, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Pseudoephedrine Cmax for Test vs. Comparator 1.
Time frame: PK Analysis: 0-48hrs
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Ibuprofen AUC0-t for Test vs. Comparator 2.
Time frame: PK Analysis: 0-48hrs
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Ibuprofen Cmax for Test vs. Comparator 2.
Time frame: PK Analysis: 0-48hrs
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
10 secondary outcomes
Ibuprofen AUC0-t for Test vs. Comparator 1.
Time frame: PK Analysis: 0-48hrs
Ibuprofen Cmax for Test vs. Comparator 1.
Time frame: PK Analysis: 0-48hrs
Assessment of how fast the ibuprofen from the Test product starts to be absorbed and how quickly it reaches the therapeutic level.
Time frame: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Time frame: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Time frame: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Time frame: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Time frame: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Time frame: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Time frame: PK Analysis: 0-48hrs
Pharmacokinetic parameters will be assessed as secondary endpoints.
Time frame: PK Analysis: 0-48hrs
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 14 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Robert Adams, MBBS principal investigator
Simbec Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules, Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets and Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules in people with Healthy, run by Reckitt Benckiser Healthcare (UK) Limited.
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 7 inclusion and 25 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 14 Jun 2017. 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?
Pseudoephedrine AUC0-t for Test vs. Comparator 1. (time frame: PK Analysis: 0-48hrs). 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 14 Jun 2017.