Bioequivalence
Conditions
Keywords
Phenyramidol, Pharmactive Ilaç San.ve Tic. A.S
Brief 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
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.
Interventions
DRUGPhenyramydol HCl 400 mg Film Tablet
Phenyramydol HCL 400 mg Film Tablet contains 400 mg phenyramydol manufactured by Pharmactive Ilac.San ve Tic A.S
DRUGCabral 400 mg Film Tablet
Cabral 400 mg Film Tablet 400 mg phenyramydol manufactured by Recordati Ilac SAn ve Tic A.S.
Sponsors
Novagenix Bioanalytical Drug R&D Center
Farmagen Ar-Ge Biyot. Ltd. Sti
Humanis Saglık Anonim Sirketi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Full replicate cross-over bioequivalence study
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Only volunteers fulfilling all of the following criteria should be enrolled in the present trial: 1. Healthy Caucasian male subjects aged between 18 and 55 years, 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during each study period, 3. Negative alcohol breath test results, 4. Normal physical examination at screening visit, 5. 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, 6. Ability to communicate adequately with the investigator himself or his/her representatives, 7. Ability and agreement to comply with the study requirements, 8. 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, 9. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest, 10. 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), 11. Understanding of the study and agreement to give a written informed consent according to section 20.3.
Exclusion criteria
Volunteers presenting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0 to 10 hours post-dose | Cmax of phenyramydol will be obtained from plasma concentrations |
| AUCt-last | 0 to 10 hours post-dose | AUC0-tlast of phenyramydol will be obtained from plasma concentrations |
| AUC0-inf | 0 to 10 hours post-dose | AUC0-inf of phenyramydol will be obtained from plasma concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tmax | 0 to 10 hours post-dose | tmax of phenyramydol will be obtained from plasma concentrations |
Countries
Turkey (Türkiye)
Outcome results
None listed