Loading clinical trials...

COMPLETEDPHASE1

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

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

NCT06180070•Humanis Saglık Anonim Sirketi

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•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.

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 such as Aspirin or other NSAIDs.
•The subject has been hospitalized within three months before the study or during the study.
•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.
+9 more criteria

Locations (1)

ACDIMA Biocenter

Amman, Jordan

Key Dates

Start Date

August 29, 2023

Primary Completion Date

September 14, 2023

Completion Date

October 16, 2023

Last Updated

December 22, 2023

Enrollment

ACTUAL participants

Conditions

MigraineHeadacheBackache

Interventions

Ibuprofen/ Paracetamol tablets

DRUG

Nuromol® tablets

DRUG

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713

Chronic Migraine

View study

RECRUITINGPHASE3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

NCT06641466

Menstrual Migraine

View study

RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

MyVitalC: Sleep and Everyday Headache Management

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine