Bioequivalence Study to Compare Diclofenac Potassium Coated Tablet Versus Cataflam® 50 Coated Tablet

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

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

Study Overview

• Status: Completed
• Conditions: Analgesic; Non-steroidal Anti-inflammatory (NSAID); Antipyretic
• Intervention / Treatment: Drug: Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium); Drug: Cataflam® 50 coated tablet

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • ACDIMA Biocenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium)	Drug: Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium); One Diclofenac tablet was administered orally.; Drug: Cataflam® 50 coated tablet; One Diclofenac tablet was administered orally.
Active Comparator: Cataflam® 50 coated tablet (50 mg Diclofenac Potassium)	Drug: Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium); One Diclofenac tablet was administered orally.; Drug: Cataflam® 50 coated tablet; One Diclofenac tablet was administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax)	Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for Cmax	10 hours
AUC0-t	Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for AUC0-t	10 hours
AUC0-∞	Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for AUC0-∞	10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax	10 hours
Thalf	Thalf was calculated from 0.693/ λz	10 hours
Kelimination	The terminal elimination rate constant (Kelimination or λz) was estimated for each subject and for each treatment via linear regression of the last points (at least three points will be used) at the terminal phase of the log-concentration versus time curve of each subject	10 hours
Blood pressure (safety and tolerability)	Clinically significant abnormal deviations. Normal range of blood pressure > 90/60 and <140/90 mmHg.	At pre-dosing, 2, 4, 6, 8, and 10 hours post dosing, ± 45 minutes of scheduled time
Pulse (safety and tolerability)	Clinically significant abnormal deviations. Normal range of Pulse 60-100 bpm.	At pre-dosing, 2, 4, 6, 8, and 10 hours post dosing, ± 45 minutes of scheduled time
Temperature(safety and tolerability)	Clinically significant abnormal deviations. Normal range of temperature 36.5-37.5 ºC.	At pre-dosing; 4, and 10 hours post dosing, ± 45 minutes of scheduled time

Collaborators and Investigators

• Sponsor: Humanis Saglık Anonim Sirketi
• Investigators: Study Director: Hakan Gürpınar, Humanis Saglık

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): September 16, 2020

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: October 16, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 974-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No