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MigrainePhase 1NCT06180070

Bioequivalence Study to Compare Ibuprofen/ Paracetamol Tablets (200mg Ibuprofen/ 500mg Paracetamol) Versus Nuromol® Tablets (200mg Ibuprofen/ 500mg Paracetamol)

A Phase 1 study testing Ibuprofen/ Paracetamol tablets and Nuromol® tablets in people with Migraine and Headache, 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
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Trial summary

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol) versus Nuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol) in healthy subjects under fasting condition. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Migraine, Headache, Backache
What is being tested?
Ibuprofen/ Paracetamol tablets and Nuromol® tablets
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
29 Aug 2023to 16 Oct 2023
Phase
Phase 1
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 Caucasian \& aged between eighteen to fifty years (18 - 50), both inclusive.
  • 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 (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
  • 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.
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  • The subject is able to understand and willing to sign the informed consent form.
  • The subject has normal cardiovascular system \& normal ECG recording with normal QT interval corrected for heart rate according to Bazett's formula.
  • The subject's kidney and liver (AST \& ALT enzymes) function tests are within normal range. (Creatinine is accepted if below the reference range after being evaluated by the clinical investigator as clinically not significant).
  • For female subjects: negative serum pregnancy test and the woman is using two reliable contraception methods and should be non-lactating.

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 such as Aspirin or other NSAIDs.
  • The subject has been hospitalized within three months before the study or during the study.
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  • The subject is on diet (for example subject is vegetarian.)
  • The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 23 hours after dosing in either study period.
  • 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/ orange containing beverages or foodstuffs within seven (7) days before 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, foodstuffs or supplements that may affect pharmacological or pharmacokinetic properties of Ibuprofen/ Paracetamol (for example: NSAIDs, corticosteroids, methotrexate, sulfamethoxazole, ACE inhibitors, beta blockers, diuretics, chlorpropamide, Chlorpropamide, quinolone antibiotics, macrolide group antibiotics, Cholestyramine, heparin and warfarin) two weeks before dosing, during the study and two weeks after dosing.
  • The subject has a history of, or active, peptic ulceration, esophagitis, gastritis, gastrointestinal bleeding or perforation, any gastrointestinal disorders or chronic inflammatory disease (e.g. ulcerative colitis, crohn's disease).
  • The subject has any signs/symptoms of an infection such as fever or pain.
  • The subject has a history of blood clotting disorders.
  • Subjects having systemic lupus erythematous or other mixed connective tissue disease.
  • Female subjects planning to become pregnant.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • ACDIMA Biocenter

    Amman

Other trials in Jordan

About this study

Official title: Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Ibuprofen/ Paracetamol Tablets (200mg Ibuprofen/ 500mg Paracetamol) Versus Nuromol® Tablets (200mg Ibuprofen/ 500mg Paracetamol) in Healthy Subjects Under Fasting Condition

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol) versus Nuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol) in healthy subjects under fasting condition.

Being tested
Ibuprofen/ Paracetamol tablets, Nuromol® tablets
Medical subject headings
Migraine Disorders, Headache, Back Pain

What participants receive

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

  • Ibuprofen/ Paracetamol tabletsDrug

    1 tablet of 200mg Ibuprofen/ 500mg Paracetamol

  • Nuromol® tabletsDrug

    1 tablet of 200mg Ibuprofen/ 500mg Paracetamol

Study groups in NCT06180070
Study groupRoleWhat they receive
Ibuprofen/ Paracetamol tabletsExperimentalIbuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol)
Receives: Drug: Ibuprofen/ Paracetamol tablets; Drug: Nuromol® tablets
Nuromol® tabletsActive comparatorNuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol)
Receives: Drug: Ibuprofen/ Paracetamol tablets; Drug: Nuromol® tablets

What is being measured

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

  1. Maximum concentration obtained (Cmax)

    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 Cmax

    Measured: 23 hours

  2. AUC from time 0 to last collection time t (AUC0-t)

    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 AUC0-t

    Measured: 23 hours

Secondary outcomes (2)

  1. AUC from time 0 to infinity (AUC0-∞)

    Descriptive Statistics

    Measured: 23 hours

  2. Time to reach maximum concentration Cmax (Tmax)

    Descriptive Statistics

    Measured: 23 hours

Timeline

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

  1. First posted22 Dec 2023
  2. Study start29 Aug 2023
  3. Primary completion14 Sep 2023
  4. Study completion16 Oct 2023

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
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06180070
Sponsor's protocol ID
1246-2023
Status last verified
Dec 2023
First submitted
5 Dec 2023
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ibuprofen/ Paracetamol tablets and Nuromol® tablets in people with Migraine and Headache, 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 19 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 22 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 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.

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 concentration obtained (Cmax) (time frame: 23 hours). The study lists 2 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 NCT06180070.

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 22 Dec 2023.

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