HealthyPhase 1NCT04678076
Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution
A Phase 1 study testing Ketoprofen Lysine and Ketoprofen Oral Product in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
Trial summary
This is a single dose, open-label, randomised, two period, two-way cross-over, two stage bioequivalenve study with the aim to investigate the bioequivalence between a new formulation of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single dose administration in two consecutive… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ketoprofen Lysine and Ketoprofen Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jul 2018to 5 Aug 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent: signed written informed consent before inclusion in the study.
- Sex and Age: males/females, 18-55 years old inclusive.
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive.
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg and heart rate 50-90 bpm, measured after 5 min of rest in the sitting position.
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
- Contraception and fertility (females only): females of child-bearing potential and with an active sexual life must be using at least one of the following reliable methods of contraception:
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- Hormonal oral, implantable, intrauterine device [IUD], transdermal or injectable contraceptives for at least 2 months before the screening visit
- A non-hormonal IUD or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
- A male sexual partner who agrees to use a male condom with spermicide
- A sterile sexual partner
- Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, pregnancy test result must be negative at screening and day -1 of each study period.
Who cannot join
- Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities.
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study.
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness.
- Allergy: ascertained or presumptive hypersensitivity to the active principles (ketoprofen) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to NSAIDs) or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory (including asthma), skin, haematological, endocrine or neurological and autoimmune diseases that may interfere with the aim of the study.
- Medications: medications, including over the counter (OTC) drugs [in particular ketoprofen, acetylsalicylic acid (ASA) and NSAIDs in general], herbal remedies and food supplements for 2 weeks before the start of the study. Paracetamol will be allowed as therapeutic counter-measure for adverse events (AEs) according to the Investigator's opinion. Hormonal contraceptives and hormone replacement therapies for females will be allowed.
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- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study (date of the informed consent signature).
- Blood donation: blood donations for 3 months before this study.
- Drug, alcohol, caffeine, tobacco: history of drug, alcohol [> 1 drink/day for females and > 2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020, caffeine (more of 5 cups coffee/tea/day) or tobacco abuse (more or equal of 6 cigarettes/day).
- Drug test: positive result at the drug test at screening or day -1 of each study period.
- Alcohol test: positive alcohol breath test at day -1 of each study period.
- Diet: abnormal diets (< 1600 or > 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians.
- Pregnancy (females only): positive or missing pregnancy test at screening or day -1 of each study period; pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bioequivalence Study of a Test Formulation of Ketoprofen Oral Gel 25 mg Versus a Marketed Reference of Ketoprofen Lysine Salt as Granules for Oral Solution (80 mg Bipartite Sachet, Half Sachet) After Single Dose Administration Under Fed Conditions to Healthy Male and Female Subjects
This is a single dose, open-label, randomised, two period, two-way cross-over, two stage bioequivalenve study with the aim to investigate the bioequivalence between a new formulation of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single dose administration in two consecutive periods to healthy voluteers under fed conditions.
Read the detailed description
The present bioequivalence phase I study has been designed to compare the bioavailability and the concentration-time profile of the new immediate release oral gel formulation of ketoprofen 25 mg with a marketed reference of ketoprofen lysine salt (KLS) as granules for oral solution (80 mg bipartite sachet, half sachet containing 40 mg of KLS, corresponding to 25 mg as ketoprofen), when administered in fed conditions to healthy male and female subjects. The study has been designed under fed conditions since the leaflet of the reference.
A two-stage design has been selected for the present study considering the margin of uncertainty existing over the sample size estimate in order to accomplish the primary study objectives in terms of ketoprofen rate (Cmax) and extent (AUC0-t) of absorption of the two formulations.
- Conditions
- Healthy
- Being tested
- Ketoprofen Lysine, Ketoprofen Oral Product
- Keywords
- ketoprofen, oral gel, ketoprofen Lysine Salt as granules, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen LysineDrug
A single oral dose of test product - ketoprofen 25 mg/5 ml oral gel stick pack - will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.
Ketoprofen Oral ProductDrug
Also called OKI 80 mg
A single oral dose of reference product as a single dose of half of a bipartite sachet of OKi® 80 mg granules for oral solution will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.
| Study group | Role | What they receive |
|---|---|---|
| ketoprofen 25mg/5ml oral gel stick pack | Experimental | Single dose of ketoprofen 25mg/5ml oral gel stick pack will be administered to healthy volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations. Receives: Drug: Ketoprofen Lysine |
| OKi 80 mg granules for oral solution (bipartite sachet) | Active comparator | Single dose of half sachet containing 40 mg of ketoprofen lysine salt (corresponding to 25 mg as ketoprofen) will be administered to healthy volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations. Receives: Drug: Ketoprofen Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration of ketoprofen
to evaluate the rate (Cmax) of absorption of ketoprofen after single oral dose of test and reference.
Measured: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Area under the concentration-time curve 0-t
to evaluate the extent (AUC0-t) of absorption after single oral dose of test and reference
Measured: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Secondary outcomes (7)
Time to achieve Cmax
to evaluate Tmax after single oral dose of test and reference products
Measured: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
t1/2
to evaluate Half-life after single oral dose of test and reference products
Measured: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
tlag after single oral dose of test and reference products
to evaluate Lag-time observed from the dosing time point prior to that of the first measurable plasma concentration
Measured: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
AUC0-∞ and residual area of ketoprofen derived from plasma concentrations after single oral dose of test and reference products;
Area under the concentration-time curve extrapolated to infinity
Measured: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Treatment-Emergent Adverse Events
to evaluate number of TEAEs and percentage of subjects with TEAEs
Measured: through study completion, an average two weeks
Blood pressure measurement
to assess diastolic and systolic blood pressure after 5 min of rest (sitting position).
Measured: pre-dose, 45 minutes and 24 hours post dose
Heart rate
to assess heart rate after 5 min of rest (sitting position).
Measured: pre-dose, 45 minutes and 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start23 Jul 2018
- Primary completion5 Aug 2018
- Study completion5 Aug 2018
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
- Model description
- Single dose, open-label, randomised, two-period, two-way cross-over, two-stage bioequivalence study.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, MD, Principal investigator, CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 CH-6864 Arzo, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678076
- Sponsor's protocol ID
- 145(B)WO17389
- Other IDs
- CRO-PK-18-326
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of a Test Formulation of Ketoprofen Oral Gel 25 mg Versus a Marketed Reference of Ketoprofen Lysine Salt as Granules for Oral Solution (80 mg Bipartite Sachet, Half Sachet) After Single Dose Administration Under Fed Conditions to Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT04678076
- Acronym / sponsor ID
- 145(B)WO17389
- Conditions
- Healthy
- Keywords
- ketoprofen, oral gel, ketoprofen Lysine Salt as granules, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 5 Aug 2018 (actual)
- Study completion
- 5 Aug 2018 (actual)
- First posted
- 21 Dec 2020 (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 is a single dose, open-label, randomised, two period, two-way cross-over, two stage bioequivalenve study with the aim to investigate the bioequivalence between a new formulation of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single dose administration in two consecutive periods to healthy voluteers under fed conditions.
Detailed description
The present bioequivalence phase I study has been designed to compare the bioavailability and the concentration-time profile of the new immediate release oral gel formulation of ketoprofen 25 mg with a marketed reference of ketoprofen lysine salt (KLS) as granules for oral solution (80 mg bipartite sachet, half sachet containing 40 mg of KLS, corresponding to 25 mg as ketoprofen), when administered in fed conditions to healthy male and female subjects. The study has been designed under fed conditions since the leaflet of the reference.
A two-stage design has been selected for the present study considering the margin of uncertainty existing over the sample size estimate in order to accomplish the primary study objectives in terms of ketoprofen rate (Cmax) and extent (AUC0-t) of absorption of the two formulations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single dose, open-label, randomised, two-period, two-way cross-over, two-stage bioequivalence study.
| Arm | Type | Receives |
|---|---|---|
| ketoprofen 25mg/5ml oral gel stick pack | Experimental | Drug: Ketoprofen LysineSingle dose of ketoprofen 25mg/5ml oral gel stick pack will be administered to healthy volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations. |
| OKi 80 mg granules for oral solution (bipartite sachet) | Active comparator | Drug: Ketoprofen Oral ProductSingle dose of half sachet containing 40 mg of ketoprofen lysine salt (corresponding to 25 mg as ketoprofen) will be administered to healthy volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Informed consent: signed written informed consent before inclusion in the study.
- Sex and Age: males/females, 18-55 years old inclusive.
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive.
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg and heart rate 50-90 bpm, measured after 5 min of rest in the sitting position.
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
Key exclusion criteria (13 listed)
- Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities.
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study.
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness.
- Allergy: ascertained or presumptive hypersensitivity to the active principles (ketoprofen) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to NSAIDs) or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory (including asthma), skin, haematological, endocrine or neurological and autoimmune diseases that may interfere with the aim of the study.
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 |
|---|---|---|
| Ketoprofen LysineA single oral dose of test product - ketoprofen 25 mg/5 ml oral gel stick pack - will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations. | Drug | ketoprofen 25mg/5ml oral gel stick pack |
| Ketoprofen Oral ProductAlso: OKI 80 mgA single oral dose of reference product as a single dose of half of a bipartite sachet of OKi® 80 mg granules for oral solution will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations. | Drug | OKi 80 mg granules for oral solution (bipartite sachet) |
Primary outcome
Maximum plasma concentration of ketoprofen
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
to evaluate the rate (Cmax) of absorption of ketoprofen after single oral dose of test and reference.
Area under the concentration-time curve 0-t
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
to evaluate the extent (AUC0-t) of absorption after single oral dose of test and reference
7 secondary outcomes
Time to achieve Cmax
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
t1/2
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
tlag after single oral dose of test and reference products
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
AUC0-∞ and residual area of ketoprofen derived from plasma concentrations after single oral dose of test and reference products;
Time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Treatment-Emergent Adverse Events
Time frame: through study completion, an average two weeks
Blood pressure measurement
Time frame: pre-dose, 45 minutes and 24 hours post dose
Heart rate
Time frame: pre-dose, 45 minutes and 24 hours post dose
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 Dec 2020.
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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.
Milko Radicioni, MD principal investigator
CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 CH-6864 Arzo, Switzerland
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 Ketoprofen Lysine and Ketoprofen Oral Product in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
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 11 inclusion and 13 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 Dec 2020. 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 Switzerland. 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?
Maximum plasma concentration of ketoprofen (time frame: pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose). The study lists 2 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 Dec 2020.