Clinica de Enfermedades Crónicas y de Procedimientos Especiales S.C.
Morelia, Mexico
NCT Number: NCT04132583
The purpose of this study was to demonstrate the bioequivalence of Deflox® 50 milligrams (mg) tablets compared with Cataflam® DD tablets 50 mg administered as single dose in fasting conditions to healthy participants.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Morelia, Mexico
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.
Other names: Diclofenac Potassium
Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.
Time frame: Pre-dose up to 24 hours Post-dose
Time frame: Pre-dose up to 24 hours Post-dose
Time frame: Pre-dose up to 24 hours Post-dose
Time frame: Pre-dose up to 24 hours Post-dose
Time frame: Pre-dose up to 24 hours Post-dose
Time frame: Pre-dose up to 24 hours Post-dose
Time frame: Pre-dose up to 24 hours Post-dose
Time frame: Baseline up to 15 days (end of study)
Time frame: Baseline up to 15 days (end of study)
Time frame: Baseline up to 15 days (end of study)
Time frame: Baseline up to 15 days (end of study)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Industry
A Randomized, Open-label, Single Dose, Two-Treatment, Two Period Crossover Design (2x2), Comparative Bioequivalence Study of Deflox® Tablets 50 mg vs Cataflam DD ® Tablets 50 mg (Innovator) in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07629414
Healthy, Heat Stress Disorders
Shreveport, Louisiana, United States
View Trial DetailsNCT07531628
Healthy
Hangzhou, China
View Trial DetailsNCT01866852
Healthy
Bethesda, Maryland, United States
View Trial DetailsNCT06354686
Healthy
Tallahassee, Florida, United States
View Trial Details