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

NCT05082662 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-12-13

No results posted yet for this study

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

Conditions

  • Non-steroidal Anti-inflammatory (NSAID)
  • Analgesic
  • Antipyretic

Interventions

DRUG

Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium)

One Diclofenac tablet was administered orally.

DRUG

Cataflam® 50 coated tablet

One Diclofenac tablet was administered orally.

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Principal Investigators

  • Hakan Gürpınar · Humanis Saglık

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2020-09-16
Completion
2020-09-16

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082662 on ClinicalTrials.gov