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

Analgesic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082662
• Other study ID #: 974-2020
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 25, 2020
• Est. completion date: September 16, 2020

Study information

• Verified date: December 2023
• Source: Humanis Saglik Anonim Sirketi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesic

Intervention

Drug:
• Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium)
One Diclofenac tablet was administered orally.
• Cataflam® 50 coated tablet
One Diclofenac tablet was administered orally.

Locations

Country	Name	City	State
Jordan	ACDIMA Biocenter	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Humanis Saglik Anonim Sirketi

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	AUC0-8	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 AUC0-8	10 hours
Secondary	Tmax	The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax	10 hours
Secondary	Thalf	Thalf was calculated from 0.693/ ?z	10 hours
Secondary	Kelimination	The terminal elimination rate constant (Kelimination or ?z) 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
Secondary	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
Secondary	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
Secondary	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