NCT06180070CompletedPhase 1

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

Humanis Saglık Anonim Sirketi1 site in 1 country36 target enrollmentStarted: August 29, 2023Last updated: December 22, 2023

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor
Enrollment: 36
Locations: 1
Primary Endpoint: AUC from time 0 to last collection time t (AUC0-t)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Other
Masking: None

Eligibility Criteria

Ages: 18 Years to 50 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Ibuprofen/ Paracetamol tablets

Experimental

Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol)

Intervention: Ibuprofen/ Paracetamol tablets (Drug)

Ibuprofen/ Paracetamol tablets

Experimental

Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol)

Intervention: Nuromol® tablets (Drug)

Nuromol® tablets

Active Comparator

Nuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol)

Intervention: Ibuprofen/ Paracetamol tablets (Drug)

Nuromol® tablets

Active Comparator

Nuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol)

Intervention: Nuromol® tablets (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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 Outcomes

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

Investigators

Sponsor

Humanis Saglık Anonim Sirketi

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (1)

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