Clinical trial NCT05082662: Bioequivalence Study to Compare Diclofenac Potassium Coated Tablet Versus Cataflam® 50 Coated Tablet
Official title: Randomized,Fully-replicated,Single Oral Dose,Open-label,Crossover BE Study to Compare Diclofenac Potassium Coated Tablet (50 mg Diclofenac Potassium) Versus Cataflam® 50 Coated Tablet (50 mg Diclofenac Potassium) in Healthy Subjects in Fasting State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-steroidal Anti-inflammatory (NSAID)
Analgesic
Antipyretic
Lead sponsor: Humanis Saglık Anonim Sirketi
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Randomized, four-way, four-period, fully-replicated, single oral dose, open-label, crossover, bioequivalence study to compare Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) versus Cataflam® 50 coated tablet (50 mg Diclofenac Potassium), in healthy subjects under fasting condition


Eligibility criteria: Inclusion Criteria:

* The subject is aged between eighteen \& fifty years (18 - 50).
* The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
* The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
* The results of medical history, vital signs, physical examination \& conducted medical laboratory tests are normal as determined by the clinical investigator.
* The subject tested negative for hepatitis (B \& C) viruses and Human Immunodeficiency Virus (HIV).
* There is no evidence of psychiatric disorder, antagonistic personality and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
* The subject is able to understand and willing to sign the informed consent form.
* For female subjects: negative pregnancy test and the woman is using two reliable contraception methods.
* The subject has normal gastrointestinal, cardiovascular system and ECG recording.
* The subject kidney and liver (AST \& ALT enzymes) functions tests are within normal range.

Exclusion Criteria:

* The subject is a heavy smoker (more than 10 cigarettes per day).
* The subject has suffered an acute illness one week before dosing.
* The subject has a history of or concurrent abuse of alcohol.
* The subject has a history of or concurrent abuse of illicit drugs.
* The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
* The subject has been hospitalized within three months before the study or during the study.
* The subject is vegetarian.
* The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 10 hours after dosing in all study periods.
* The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
* The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
* The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
* The subject has donated blood within 80 days before first dosing.
* The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
* The subject has consumed drugs that may affect pharmacological or pharmacokinetic properties (Voriconazole and Aspirin) two weeks before dosing, during the study and two weeks after dosing.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 10 hours
measure: AUC0-t
timeFrame: 10 hours
measure: AUC0-∞
timeFrame: 10 hours
Secondary outcomes:
measure: Tmax
timeFrame: 10 hours
measure: Thalf
timeFrame: 10 hours
measure: Kelimination
timeFrame: 10 hours
measure: Blood pressure (safety and tolerability)
timeFrame: At pre-dosing, 2, 4, 6, 8, and 10 hours post dosing, ± 45 minutes of scheduled time
measure: Pulse (safety and tolerability)
timeFrame: At pre-dosing, 2, 4, 6, 8, and 10 hours post dosing, ± 45 minutes of scheduled time
measure: Temperature(safety and tolerability)
timeFrame: At pre-dosing; 4, and 10 hours post dosing, ± 45 minutes of scheduled time
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: ACDIMA Biocenter
Study officials:
affiliation: Humanis Saglık
name: Hakan Gürpınar
role: STUDY_DIRECTOR
References: