HealthyPhase 1NCT03697889
A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers
A Phase 1 study testing Naproxen sodium (test product) and Naproxen sodium (reference product) in people with Healthy, run by McNeil AB at 1 site in Russia.
Trial summary
This is a research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Naproxen sodium (test product) and Naproxen sodium (reference product)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteRussia
- Study dates
- 3 Dec 2018to 21 Jan 2019
- 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
- Healthy male or female subject between the ages of 18 and 45 years, inclusive. Healthy is defined as the absence of any disease or abnormalities (including positive test for human immunodeficiency virus (HIV) 1 or 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV) or syphilis (RW)) as judged by the investigator on the basis of a detailed medical history, physical examination, blood pressure, pulse rate measurements, 12-lead electrocardiogram, as well as clinical laboratory tests. The responsible investigator may request additional investigations or analyses if necessary
- Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine-containing product for at least 12 months before 1st dose of the study drug in this study.
- Females: Postmenopausal state (absence of menstrual discharge for at least two years and a follicle stimulating hormone (FSH) serum level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, or transdermal hormonal contraceptives, vaginal contraceptive ring, intrauterine device, or status after operative sterilization) during the study and 30 days thereafter, single male partner who has had a vasectomy, or abstinence from heterosexual intercourse, during the study and 30 days thereafter.
- Males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study and 30 days thereafter.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 with a total body weight >50 kg.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.
Who cannot join
- Use of medications other than contraceptives specified in Inclusion criterion 3 or occasional use of other medications approved by the Investigator.
- Use of any vitamins, dietary and herbal supplements within 7 days before each dose of study drugs.
- Use of any nonprescription or prescription medications, including naproxen medications, other than contraceptives, within 5 times the drug's half-life before each dose of study drug.
- Depot injection or an implant of any drug within 3 months prior to dosing.
- History of any allergy or hypersensitivity (e.g. skin reaction, asthma, angioedema) to naproxen, ibuprofen, ASA, other NSAIDs or any related products (including excipients of the formulations).
- Females: Confirmed pregnancy or a positive pregnancy test at the screening visit, or planning to become pregnant during the duration of the study, and/or breast-feeding
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- Has a history of peptic ulcers, gastrointestinal bleeding of any etiology, bleeding disorders, gastrointestinal disease (including chronic heartburn or gastroesophageal reflux disease), inflammatory bowel disease (ulcerative colitis, Crohn's disease), or gastrointestinal surgery other than appendectomy.
- Has asthma, hypertension, fluid retention, or heart disease either by history or by the medically qualified principal investigator's medical judgment; has hemophilia and other disorders of blood clotting and hemostasis disorders, has cerebrovascular hemorrhage or other hemorrhages;
- Has renal or hepatic impairment; according to the medically qualified investigator discretion;
- Acute infectious disease within 4 weeks prior to screening.
- Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
- Preplanned surgical procedures during the study period, if this may interfere with the conduct of the study.
- History of alcoholism defined as alcohol consumption in the 6 months before screening that exceeds weekly limits of 10 alcohol units (2 L of wine or 5 L of beer or 0.5 L of spirits) or substance abuse, as judged by the Investigator, within the past 6 months preceding this study.
- Consumed alcohol beverage(s) within 48 hours prior to the first scheduled dose of the study drug, positive respiratory alcohol test at screening, or inability to abstain from alcohol consumption during the entire study period.
- Positive urine screen for drug abuse.
- Use of xanthine containing products (e.g., coffee, tea, chocolate or cola drink) within 48 hours before each dose of study drug.
- Ingestion of food or beverages containing grapefruit, Chinese grapefruit (pomelo) or Seville oranges (including marmalade) within 10 days before the first dose of study drug and throughout the study.
- Donation or loss of blood within 3 months prior to the first dose of study drug if the estimated lost blood volume equaled or exceeded 450 mL.
- Abnormal results of laboratory and instrumental methods of examinations, including electrocardiogram (ECG) at screening;
- Heart rate <60 or >90 per minute at rest, or systolic blood pressure <100 or >130 mm Hg, or diastolic blood pressure <70 or >90 mm Hg measured at screening visit.
- Has any acute or chronic, medical or psychiatric condition(s) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the medically qualified investigator, would make the subject inappropriate for entry into this study;
- Relationship to persons involved directly in the conduct of the study (i.e., principal investigator, subinvestigators,study coordinators, other study personnel, employees or contractors of the sponsor or Johnson \& Johnson subsidiaries, and the family of each).
Trial locations and contacts
1 site in 1 country.
Russia1 site
LLC "Scientific and Research centre Eco-safety"
Saint Petersburg, 196143
About this study
Official title: An Open-label, Randomized, Single-dose, Two-treatment, Crossover Bioequivalence Study Comparing a Novel Naproxen Sodium 275 mg Film-coated Tablet (BILIM ILAC SANAYII VE TICARET A.S., TURKEY) and Nalgesin® 275 mg Naproxen Sodium Film-coated Tablet (JSC "KRKA, D.D., NOVO MESTO", SLOVENIA), in Healthy Adult Volunteers
This is a research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg.
Read the detailed description
The study has an open-label, randomized, two-way crossover design. 28 healthy participants will be included. Single-doses of 1 tablet of Naproxen sodium 275 mg and Nalgesin 275 mg will be given on separate treatment visits to healthy adult participants under fasting conditions. A crossover design is chosen in order to allow within-subject comparisons of treatments. To minimize the risk of carry-over effect, the washout period between the study drug administrations is set to 7 days. The study is open-label because the primary data collected are concentration measurements that cannot be expected to be affected by a participant's knowledge of the product administered.
- Conditions
- Healthy
- Being tested
- Naproxen sodium (test product), Naproxen sodium (reference product)
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen sodium (test product)Drug
Participants will be administered single doses of 275 mg Naproxen sodium (test product) tablet orally.
Naproxen sodium (reference product)Drug
Also called Nalgesin
Participants will be administered single doses of 275 mg Naproxen sodium (reference product - Nalgesin) tablet orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | Participants will receive Treatment A (test product Naproxen sodium tablet, 1 x 275 mg) at dosing period 1 followed by Treatment B (reference product Nalgesin, 1 x 275 mg) dosing period 2. There is a wash-out period of 7 days between the two dosing periods. Receives: Drug: Naproxen sodium (test product); Drug: Naproxen sodium (reference product) |
| Treatment Sequence BA | Experimental | Participants will receive Treatment B (reference product Nalgesin, 1 x 275 mg) at dosing period 1 followed by Treatment A (test product Naproxen sodium tablet, 1 x 275 mg) at dosing period 2. There is a wash-out period of 7 days between the two dosing periods. Receives: Drug: Naproxen sodium (test product); Drug: Naproxen sodium (reference product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum observed plasma concentrations (Cmax) of Naproxen Sodium
The maximum observed plasma concentration (Cmax)
Measured: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The area under the plasma concentration-vs.-time curves from start of Naproxen sodium administration until the time of the last measurable concentration (AUCt)
AUCt is defines as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
Measured: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
Secondary outcomes (6)
The area under the plasma concentration-vs.-time curve from the start of Naproxen sodium administration extrapolated to infinity (AUC∞)
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the nicotine plasma concentration is negligible (infinity).
Measured: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The extrapolated part of AUC∞, AUCExtrap
Measured: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The time at which maximum Naproxen sodium concentraton (Cmax) is observed (Tmax)
Tmax is defined as the time point at which the maximum nicotine concentration (Cmax) occurs
Measured: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The terminal elimination rate constant (lambda-z) for Naproxen sodium
The rate at which the drug is removed from the body system.
Measured: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The terminal elimination half-life (t1/2) of Naproxen sodium
The time taken for the Naproxen sodium plasma concentration to fall to half its original value.
Measured: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
Number of participants with Adverse Events
An AE is any untoward from a medical standpoint event occurred in patient or subject of clinical study after the use of a medicinal product which may or may not have a causal relationship with its use.
Measured: Approximately 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start3 Dec 2018
- Primary completion17 Dec 2018
- Study completion21 Jan 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konstantin A. Zacharov, MD, Principal investigator, LLC "Scientific and Research centre Eco-safety"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697889
- Sponsor's protocol ID
- CO-171115092223-PACT
- Status last verified
- Jan 2020
- First submitted
- 4 Oct 2018
- Last updated
- 23 Jan 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 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Two-treatment, Crossover Bioequivalence Study Comparing a Novel Naproxen Sodium 275 mg Film-coated Tablet (BILIM ILAC SANAYII VE TICARET A.S., TURKEY) and Nalgesin® 275 mg Naproxen Sodium Film-coated Tablet (JSC "KRKA, D.D., NOVO MESTO", SLOVENIA), in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03697889
- Acronym / sponsor ID
- CO-171115092223-PACT
- Conditions
- Healthy
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 5 Oct 2018 (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 research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg.
Detailed description
The study has an open-label, randomized, two-way crossover design. 28 healthy participants will be included. Single-doses of 1 tablet of Naproxen sodium 275 mg and Nalgesin 275 mg will be given on separate treatment visits to healthy adult participants under fasting conditions. A crossover design is chosen in order to allow within-subject comparisons of treatments. To minimize the risk of carry-over effect, the washout period between the study drug administrations is set to 7 days. The study is open-label because the primary data collected are concentration measurements that cannot be expected to be affected by a participant's knowledge of the product administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: Naproxen sodium (test product), Drug: Naproxen sodium (reference product)Participants will receive Treatment A (test product Naproxen sodium tablet, 1 x 275 mg) at dosing period 1 followed by Treatment B (reference product Nalgesin, 1 x 275 mg) dosing period 2. There is a wash-out period of 7 days between the two dosing periods. |
| Treatment Sequence BA | Experimental | Drug: Naproxen sodium (test product), Drug: Naproxen sodium (reference product)Participants will receive Treatment B (reference product Nalgesin, 1 x 275 mg) at dosing period 1 followed by Treatment A (test product Naproxen sodium tablet, 1 x 275 mg) at dosing period 2. There is a wash-out period of 7 days between the two dosing periods. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female subject between the ages of 18 and 45 years, inclusive. Healthy is defined as the absence of any disease or abnormalities (including positive test for human immunodeficiency virus (HIV) 1 or 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV) or syphilis (RW)) as judged by the investigator on the basis of a detailed medical history, physical examination, blood pressure, pulse rate measurements, 12-lead electrocardiogram, as well as clinical laboratory tests. The responsible investigator may request additional investigations or analyses if necessary
- Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine-containing product for at least 12 months before 1st dose of the study drug in this study.
- Females: Postmenopausal state (absence of menstrual discharge for at least two years and a follicle stimulating hormone (FSH) serum level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, or transdermal hormonal contraceptives, vaginal contraceptive ring, intrauterine device, or status after operative sterilization) during the study and 30 days thereafter, single male partner who has had a vasectomy, or abstinence from heterosexual intercourse, during the study and 30 days thereafter.
- Males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study and 30 days thereafter.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 with a total body weight >50 kg.
Key exclusion criteria (22 listed)
- Use of medications other than contraceptives specified in Inclusion criterion 3 or occasional use of other medications approved by the Investigator.
- Use of any vitamins, dietary and herbal supplements within 7 days before each dose of study drugs.
- Use of any nonprescription or prescription medications, including naproxen medications, other than contraceptives, within 5 times the drug's half-life before each dose of study drug.
- Depot injection or an implant of any drug within 3 months prior to dosing.
- History of any allergy or hypersensitivity (e.g. skin reaction, asthma, angioedema) to naproxen, ibuprofen, ASA, other NSAIDs or any related products (including excipients of the formulations).
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 |
|---|---|---|
| Naproxen sodium (test product)Participants will be administered single doses of 275 mg Naproxen sodium (test product) tablet orally. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| Naproxen sodium (reference product)Also: NalgesinParticipants will be administered single doses of 275 mg Naproxen sodium (reference product - Nalgesin) tablet orally. | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
The maximum observed plasma concentrations (Cmax) of Naproxen Sodium
Time frame: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The maximum observed plasma concentration (Cmax)
The area under the plasma concentration-vs.-time curves from start of Naproxen sodium administration until the time of the last measurable concentration (AUCt)
Time frame: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
AUCt is defines as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
6 secondary outcomes
The area under the plasma concentration-vs.-time curve from the start of Naproxen sodium administration extrapolated to infinity (AUC∞)
Time frame: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The extrapolated part of AUC∞, AUCExtrap
Time frame: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The time at which maximum Naproxen sodium concentraton (Cmax) is observed (Tmax)
Time frame: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The terminal elimination rate constant (lambda-z) for Naproxen sodium
Time frame: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
The terminal elimination half-life (t1/2) of Naproxen sodium
Time frame: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration
Number of participants with Adverse Events
Time frame: Approximately 26 days
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 Jan 2020.
- Synopsis to support result registration for a clinical study performed within the Russian federation.Link provided by the sponsor.
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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.
Konstantin A. Zacharov, MD principal investigator
LLC "Scientific and Research centre Eco-safety"
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 Naproxen sodium (test product) and Naproxen sodium (reference product) in people with Healthy, run by McNeil AB at 1 site in Russia.
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 22 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 Jan 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 Russia. 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?
The maximum observed plasma concentrations (Cmax) of Naproxen Sodium (time frame: 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration). 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 23 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.