AzTrials
AzTrials

Non-steroidal Anti-inflammatory (NSAID)Phase 1/2NCT05082662

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

A Phase 1/2 study testing Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) and Cataflam® 50 coated tablet in people with Non-steroidal Anti-inflammatory (NSAID) and Analgesic, run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) and Cataflam® 50 coated tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteJordan
Study dates
25 Aug 2020to 16 Sep 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • ACDIMA Biocenter

    Amman

Other trials in Jordan

About this study

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

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

Being tested
Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium), Cataflam® 50 coated tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium)Drug

    One Diclofenac tablet was administered orally.

  • Cataflam® 50 coated tabletDrug

    One Diclofenac tablet was administered orally.

Study groups in NCT05082662
Study groupRoleWhat they receive
Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium)ExperimentalNot described
Receives: Drug: Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium); Drug: Cataflam® 50 coated tablet
Cataflam® 50 coated tablet (50 mg Diclofenac Potassium)Active comparatorNot described
Receives: Drug: Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium); Drug: Cataflam® 50 coated tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 10 hours

  2. 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

    Measured: 10 hours

  3. 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-∞

    Measured: 10 hours

Secondary outcomes (6)

  1. Tmax

    The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax

    Measured: 10 hours

  2. Thalf

    Thalf was calculated from 0.693/ λz

    Measured: 10 hours

  3. 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

    Measured: 10 hours

  4. Blood pressure (safety and tolerability)

    Clinically significant abnormal deviations. Normal range of blood pressure > 90/60 and <140/90 mmHg.

    Measured: At pre-dosing, 2, 4, 6, 8, and 10 hours post dosing, ± 45 minutes of scheduled time

  5. Pulse (safety and tolerability)

    Clinically significant abnormal deviations. Normal range of Pulse 60-100 bpm.

    Measured: At pre-dosing, 2, 4, 6, 8, and 10 hours post dosing, ± 45 minutes of scheduled time

  6. Temperature(safety and tolerability)

    Clinically significant abnormal deviations. Normal range of temperature 36.5-37.5 ºC.

    Measured: At pre-dosing; 4, and 10 hours post dosing, ± 45 minutes of scheduled time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start25 Aug 2020
  3. Primary completion16 Sep 2020
  4. Study completion16 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05082662
Sponsor's protocol ID
974-2020
Status last verified
Dec 2023
First submitted
14 Sep 2021
Last updated
13 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) and Cataflam® 50 coated tablet in people with Non-steroidal Anti-inflammatory (NSAID) and Analgesic, run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed plasma concentration (Cmax) (time frame: 10 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05082662.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in