BioequivalencePhase 1PHENYRAMIDOLNCT04639869
Bioequivalence Study of Feniramidol HCl 400 mg Film Tablet (Pharmactive, Turkey) Under Fed Conditions
A Phase 1 study testing Phenyramydol HCl 400 mg Film Tablet and Cabral 400 mg Film Tablet in people with Bioequivalence, run by Humanis Saglık Anonim Sirketi at 1 site in Turkey (Türkiye).
Trial summary
OPEN-LABEL, RANDOMISED, SINGLE ORAL DOSE, FOUR-PERIOD, REPLICATED, CROSS-OVER TRIAL TO ASSESS THE BIOEQUIVALENCE OF FENIRAMIDOL HCl 400 MG FILM TABLET (TEST DRUG) IN COMPARISON WITH CABRAL 400 MG FILM TABLET (REFERENCE DRUG) IN HEALTHY MALE SUBJECTS UNDER FED CONDITIONS Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Phenyramydol HCl 400 mg Film Tablet and Cabral 400 mg Film Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2019to 27 Aug 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only volunteers fulfilling all of the following criteria should be enrolled in the present trial:
- Healthy Caucasian male subjects aged between 18 and 55 years,
- Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during each study period,
- Negative alcohol breath test results,
- Normal physical examination at screening visit,
- Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age,
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- Ability to communicate adequately with the investigator himself or his/her representatives,
- Ability and agreement to comply with the study requirements,
- Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm,
- Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest,
- Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate),
- Understanding of the study and agreement to give a written informed consent according to section 20.3.
Who cannot join
- Volunteers presenting any of the following exclusion criteria will not be included in the trial:
- Who have atopic constitution or asthma and/or known allergy for phenyramidol HCl or any other ingredients of the products.
- Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria.
- Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator).
- Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
- Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration.
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- Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement.
- Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product).
- Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- History of allergic response to heparin.
- Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.
- Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day.
- Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study, or during the washout periods.
- History of drug abuse.
- History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits).
- Positive blood test for HBV, HCV and HIV.
- Who have relationship to the investigator.
- Who are not suitable to any of inclusion criteria.
- History of difficulty of swallowing.
- Intake of depot injectable solutions (including study medications) within 6 months before start of the study.
- Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.
- Special diet due to any reason, e.g. vegetarian.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Novagenix Drug R&D Center
Akyurt, Ankara, 06970
About this study
Official title: Open-label, Randomized, Single Dose, 4period, Replicated, Cross-over Trial to Assess the Bioequivalence of Feniramidol HCl 400 mg Film Tablet in Comparison With Cabral 400 mg Film Tablet in Healthy Male Subjects Under Fed Conditions
OPEN-LABEL, RANDOMISED, SINGLE ORAL DOSE, FOUR-PERIOD, REPLICATED, CROSS-OVER TRIAL TO ASSESS THE BIOEQUIVALENCE OF FENIRAMIDOL HCl 400 MG FILM TABLET (TEST DRUG) IN COMPARISON WITH CABRAL 400 MG FILM TABLET (REFERENCE DRUG) IN HEALTHY MALE SUBJECTS UNDER FED CONDITIONS
Read the detailed description
Phenyramidol shows its muscle relaxant activity by interneuronal blockage without disrupting neuromuscular function. Thus, it relieves muscle spasm, and breaks pain-spasm chain by blocking polisynaptic reflexes in the brain and medulla spinalis. It does not affect monosynaptic reflexes.
Phenyramidol has a very high analgesic effect than aspirin and close to codeine. It used in the treatment of acute and chronic human musculoskeletal system pains as muscle relaxant and analgesic.
Pharmacokinetics Phenyramidol reaches maximum plasma concentration in an hour (0.25-1) after absorption from gastrointestinal tract. It is widely distributed in skeletal muscles and involved in circulatory system very slowly.
Studies have shown that cytochrome P450 enzymes are effective in phenyramidol metabolism. It is conjugated with glucuronic acid in the liver and it is excreted as glucuronide conjugates from the urinary tract. The drug is eliminated from the bile and the bacterial glucuronidase enzymes make the glucuronide conjugate of phenyramidol free. The drug enters enterohepatic circulation and is excreted by faeces. Its elimination half-life is 1-2 hours.
Indications Phenyramidol is indicated in the symptomatic treatment of acute painful muscle spasms associated with musculoskeletal system.
- Conditions
- Bioequivalence
- Being tested
- Phenyramydol HCl 400 mg Film Tablet, Cabral 400 mg Film Tablet
- Keywords
- Phenyramidol, Pharmactive Ilaç San.ve Tic. A.S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenyramydol HCl 400 mg Film TabletDrug
Also called Test Phenyramydol
Phenyramydol HCL 400 mg Film Tablet contains 400 mg phenyramydol manufactured by Pharmactive Ilac.San ve Tic A.S
Cabral 400 mg Film TabletDrug
Also called Reference Phenyramydol
Cabral 400 mg Film Tablet 400 mg phenyramydol manufactured by Recordati Ilac SAn ve Tic A.S.
| Study group | Role | What they receive |
|---|---|---|
| Phenyramydol then Cabral | Experimental | Participants first receive Phenyramydol HCl 400 mg Film Tablet manufactured by Pharmactive Ilac San ve Tİc A.S. in fed state. After a wash out period of 7 days, they then received Cabral 400 mg Film Tablet manufactured by Recordati Ilac San ve Tİc A.S. in fed state Receives: Drug: Phenyramydol HCl 400 mg Film Tablet; Drug: Cabral 400 mg Film Tablet |
| Cabral then Phenyramydol | Active comparator | Participants first receive Cabral 400 mg Film Tablet manufactured by Recordati Ilac San ve Tİc A.S. in fed state. After a wash out period of 7 days, they then received Phenyramydol HCl 400 mg Film Tablet manufactured by Pharmactive Ilac San ve Tİc A.S.in fed state Receives: Drug: Phenyramydol HCl 400 mg Film Tablet; Drug: Cabral 400 mg Film Tablet |
| Phenyramydol then Cabral Replicate | Experimental | Participants first receive Phenyramydol HCl 400 mg Film Tablet manufactured by Pharmactive Ilac San ve Tİc A.S. in fed state. After a wash out period of 7 days, they then received Cabral 400 mg Film Tablet manufactured by Recordati Ilac San ve Tİc A.S. in fed state Receives: Drug: Phenyramydol HCl 400 mg Film Tablet; Drug: Cabral 400 mg Film Tablet |
| Cabral then Phenyramydol Replicate | Active comparator | Participants first receive Cabral 400 mg Film Tablet manufactured by Recordati Ilac San ve Tİc A.S. in fed state. After a wash out period of 7 days, they then received Phenyramydol HCl 400 mg Film Tablet manufactured by Pharmactive Ilac San ve Tİc A.S.in fed state Receives: Drug: Phenyramydol HCl 400 mg Film Tablet; Drug: Cabral 400 mg Film Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Cmax of phenyramydol will be obtained from plasma concentrations
Measured: 0 to 10 hours post-dose
AUCt-last
AUC0-tlast of phenyramydol will be obtained from plasma concentrations
Measured: 0 to 10 hours post-dose
AUC0-inf
AUC0-inf of phenyramydol will be obtained from plasma concentrations
Measured: 0 to 10 hours post-dose
Secondary outcomes (1)
tmax
tmax of phenyramydol will be obtained from plasma concentrations
Measured: 0 to 10 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 posted23 Nov 2020
- Study start26 Jun 2019
- Primary completion26 Jul 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Full replicate cross-over bioequivalence study
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novagenix Bioanalytical Drug R&D Center, Farmagen Ar-Ge Biyot. Ltd. Sti
- Responsible party
- Sponsor
- Investigators
- Muradiye Nacak, MD,PhD, Principal investigator, Farmagen Ar-Ge Biyot. Ltd. StiTaner Ezgi, MD, Study chair, Farmagen Ar-Ge Biyot. Ltd. StiHakan Gürpınar, MSc, Study director, Pharmactive İlaç San.ve Tic.A.S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639869
- Sponsor's protocol ID
- NOV2019/01864
- Acronym
- PHENYRAMIDOL
- Status last verified
- Nov 2020
- First submitted
- 29 Sep 2020
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Single Dose, 4period, Replicated, Cross-over Trial to Assess the Bioequivalence of Feniramidol HCl 400 mg Film Tablet in Comparison With Cabral 400 mg Film Tablet in Healthy Male Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT04639869
- Acronym / sponsor ID
- PHENYRAMIDOL / NOV2019/01864
- Conditions
- Bioequivalence
- Keywords
- Phenyramidol, Pharmactive Ilaç San.ve Tic. A.S
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Collaborators
- Novagenix Bioanalytical Drug R&D Center, Farmagen Ar-Ge Biyot. Ltd. Sti
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 23 Nov 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.
OPEN-LABEL, RANDOMISED, SINGLE ORAL DOSE, FOUR-PERIOD, REPLICATED, CROSS-OVER TRIAL TO ASSESS THE BIOEQUIVALENCE OF FENIRAMIDOL HCl 400 MG FILM TABLET (TEST DRUG) IN COMPARISON WITH CABRAL 400 MG FILM TABLET (REFERENCE DRUG) IN HEALTHY MALE SUBJECTS UNDER FED CONDITIONS
Detailed description
Phenyramidol shows its muscle relaxant activity by interneuronal blockage without disrupting neuromuscular function. Thus, it relieves muscle spasm, and breaks pain-spasm chain by blocking polisynaptic reflexes in the brain and medulla spinalis. It does not affect monosynaptic reflexes.
Phenyramidol has a very high analgesic effect than aspirin and close to codeine. It used in the treatment of acute and chronic human musculoskeletal system pains as muscle relaxant and analgesic.
Pharmacokinetics Phenyramidol reaches maximum plasma concentration in an hour (0.25-1) after absorption from gastrointestinal tract. It is widely distributed in skeletal muscles and involved in circulatory system very slowly.
Studies have shown that cytochrome P450 enzymes are effective in phenyramidol metabolism. It is conjugated with glucuronic acid in the liver and it is excreted as glucuronide conjugates from the urinary tract. The drug is eliminated from the bile and the bacterial glucuronidase enzymes make the glucuronide conjugate of phenyramidol free. The drug enters enterohepatic circulation and is excreted by faeces. Its elimination half-life is 1-2 hours.
Indications Phenyramidol is indicated in the symptomatic treatment of acute painful muscle spasms associated with musculoskeletal system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Full replicate cross-over bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Phenyramydol then Cabral | Experimental | Drug: Phenyramydol HCl 400 mg Film Tablet, Drug: Cabral 400 mg Film TabletParticipants first receive Phenyramydol HCl 400 mg Film Tablet manufactured by Pharmactive Ilac San ve Tİc A.S. in fed state. After a wash out period of 7 days, they then received Cabral 400 mg Film Tablet manufactured by Recordati Ilac San ve Tİc A.S. in fed state |
| Cabral then Phenyramydol | Active comparator | Drug: Phenyramydol HCl 400 mg Film Tablet, Drug: Cabral 400 mg Film TabletParticipants first receive Cabral 400 mg Film Tablet manufactured by Recordati Ilac San ve Tİc A.S. in fed state. After a wash out period of 7 days, they then received Phenyramydol HCl 400 mg Film Tablet manufactured by Pharmactive Ilac San ve Tİc A.S.in fed state |
| Phenyramydol then Cabral Replicate | Experimental | Drug: Phenyramydol HCl 400 mg Film Tablet, Drug: Cabral 400 mg Film TabletParticipants first receive Phenyramydol HCl 400 mg Film Tablet manufactured by Pharmactive Ilac San ve Tİc A.S. in fed state. After a wash out period of 7 days, they then received Cabral 400 mg Film Tablet manufactured by Recordati Ilac San ve Tİc A.S. in fed state |
| Cabral then Phenyramydol Replicate | Active comparator | Drug: Phenyramydol HCl 400 mg Film Tablet, Drug: Cabral 400 mg Film TabletParticipants first receive Cabral 400 mg Film Tablet manufactured by Recordati Ilac San ve Tİc A.S. in fed state. After a wash out period of 7 days, they then received Phenyramydol HCl 400 mg Film Tablet manufactured by Pharmactive Ilac San ve Tİc A.S.in fed state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Only volunteers fulfilling all of the following criteria should be enrolled in the present trial:
- Healthy Caucasian male subjects aged between 18 and 55 years,
- Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during each study period,
- Negative alcohol breath test results,
- Normal physical examination at screening visit,
Key exclusion criteria (22 listed)
- Volunteers presenting any of the following exclusion criteria will not be included in the trial:
- Who have atopic constitution or asthma and/or known allergy for phenyramidol HCl or any other ingredients of the products.
- Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria.
- Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator).
- Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
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 |
|---|---|---|
| Phenyramydol HCl 400 mg Film TabletAlso: Test PhenyramydolPhenyramydol HCL 400 mg Film Tablet contains 400 mg phenyramydol manufactured by Pharmactive Ilac.San ve Tic A.S | Drug | Cabral then Phenyramydol, Cabral then Phenyramydol Replicate, Phenyramydol then Cabral, Phenyramydol then Cabral Replicate |
| Cabral 400 mg Film TabletAlso: Reference PhenyramydolCabral 400 mg Film Tablet 400 mg phenyramydol manufactured by Recordati Ilac SAn ve Tic A.S. | Drug | Cabral then Phenyramydol, Cabral then Phenyramydol Replicate, Phenyramydol then Cabral, Phenyramydol then Cabral Replicate |
Primary outcome
Cmax
Time frame: 0 to 10 hours post-dose
Cmax of phenyramydol will be obtained from plasma concentrations
AUCt-last
Time frame: 0 to 10 hours post-dose
AUC0-tlast of phenyramydol will be obtained from plasma concentrations
AUC0-inf
Time frame: 0 to 10 hours post-dose
AUC0-inf of phenyramydol will be obtained from plasma concentrations
1 secondary outcome
tmax
Time frame: 0 to 10 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 28 Sep 2023.
- 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.
Muradiye Nacak, MD,PhD principal investigator
Farmagen Ar-Ge Biyot. Ltd. Sti
Taner Ezgi, MD study chair
Farmagen Ar-Ge Biyot. Ltd. Sti
Hakan Gürpınar, MSc study director
Pharmactive İlaç San.ve Tic.A.S
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 Phenyramydol HCl 400 mg Film Tablet and Cabral 400 mg Film Tablet in people with Bioequivalence, run by Humanis Saglık Anonim Sirketi at 1 site in Turkey (Türkiye).
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 12 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 28 Sep 2023. 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 Turkey (Türkiye). 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?
Cmax (time frame: 0 to 10 hours post-dose). The study lists 3 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 28 Sep 2023.