Bioequivalence Study of Feniramidol HCl 400 mg Film Tablet (Pharmactive, Turkey) Under Fed Conditions

NCT04639869 | Completed Phase 1

• 1 other identifier: NOV2019/01864
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Bioequivalence

Keywords

Phenyramidol; Pharmactive Ilaç San.ve Tic. A.S

Outcome Measures

Primary Outcomes (3)

• Cmax

  Cmax of phenyramydol will be obtained from plasma concentrations

  0 to 10 hours post-dose

• AUCt-last

  AUC0-tlast of phenyramydol will be obtained from plasma concentrations

  0 to 10 hours post-dose

• AUC0-inf

  AUC0-inf of phenyramydol will be obtained from plasma concentrations

  0 to 10 hours post-dose

Secondary Outcomes (1)

• tmax

  0 to 10 hours post-dose

Study Arms (4)

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

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

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

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

Drug: Phenyramydol HCl 400 mg Film Tablet; Drug: Cabral 400 mg Film Tablet

Interventions

Phenyramydol HCl 400 mg Film Tablet DRUG

Phenyramydol HCL 400 mg Film Tablet contains 400 mg phenyramydol manufactured by Pharmactive Ilac.San ve Tic A.S

Also known as: Test Phenyramydol

Cabral then Phenyramydol; Cabral then Phenyramydol Replicate; Phenyramydol then Cabral; Phenyramydol then Cabral Replicate

Cabral 400 mg Film Tablet DRUG

Cabral 400 mg Film Tablet 400 mg phenyramydol manufactured by Recordati Ilac SAn ve Tic A.S.

Also known as: Reference Phenyramydol

Cabral then Phenyramydol; Cabral then Phenyramydol Replicate; Phenyramydol then Cabral; Phenyramydol then Cabral Replicate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead
• Novagenix Bioanalytical Drug R&D Center: collaborator
• Farmagen Ar-Ge Biyot. Ltd. Sti: collaborator

Study Sites (1)

Novagenix Drug R&D Center

Akyurt, Ankara, 06970, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Motion Pictures

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Muradiye Nacak, MD,PhD

  Farmagen Ar-Ge Biyot. Ltd. Sti

  PRINCIPAL INVESTIGATOR

• Taner Ezgi, MD

  Farmagen Ar-Ge Biyot. Ltd. Sti

  STUDY CHAIR

• Hakan Gürpınar, MSc

  Pharmactive İlaç San.ve Tic.A.S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Full replicate cross-over bioequivalence study

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 23, 2020
• Study Start: June 26, 2019
• Primary Completion: July 26, 2019
• Study Completion: August 27, 2019
• Last Updated: September 28, 2023

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)