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

Phase 1

Completed

• Conditions: Migraine; Headache; Backache
• Interventions: Drug: Ibuprofen/ Paracetamol tablets; Drug: Nuromol® tablets

• Registration Number: NCT06180070
• Lead Sponsor: Humanis Saglık Anonim Sirketi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-29
• Primary Completion: 2023-09-14
• Study Completion: 2023-10-16
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-22
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ibuprofen/ Paracetamol tablets	Ibuprofen/ Paracetamol tablets	Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol)
Ibuprofen/ Paracetamol tablets	Nuromol® tablets	Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol)
Nuromol® tablets	Ibuprofen/ Paracetamol tablets	Nuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol)
Nuromol® tablets	Nuromol® tablets	Nuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol)

Primary Outcome Measures

Name	Time	Method
AUC from time 0 to last collection time t (AUC0-t)	23 hours	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
Maximum concentration obtained (Cmax)	23 hours	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

Secondary Outcome Measures

Name	Time	Method
AUC from time 0 to infinity (AUC0-∞)	23 hours	Descriptive Statistics
Time to reach maximum concentration Cmax (Tmax)	23 hours	Descriptive Statistics

Trial Locations

Locations (1)

ACDIMA Biocenter; 🇯🇴 Amman, Jordan