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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Deflox®, Then Cataflam DD® | Experimental | Participants received single oral dose of Deflox® 50 milligrams (mg) tablet in Treatment Period 1 followed by a single oral dose of Cataflam DD® 50 mg tablet in Treatment Period 2 under fasting condition. A wash-out period of 7 days was maintained between the Treatment Periods 1 and 2. |
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| First Cataflam DD®, Then Deflox® | Experimental | Participants received single oral dose of Cataflam DD® 50 mg tablet in Treatment Period 1 followed by single oral dose of Deflox® 50 mg tablet in Treatment Period 2 under fasting condition. A wash-out period of 7 days was maintained between Treatment Periods 1 and 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deflox® | Drug | Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Diclofenac | Pre-dose up to 24 hours Post-dose | |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Diclofenac | Pre-dose up to 24 hours Post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of Diclofenac | Pre-dose up to 24 hours Post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) of Diclofenac | Pre-dose up to 24 hours Post-dose | |
| Terminal Elimination Half-Life (t1/2) of Diclofenac | Pre-dose up to 24 hours Post-dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica de Enfermedades Crónicas y de Procedimientos Especiales S.C. | Morelia | Mexico |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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| ID | Term |
|---|---|
| C041226 | Terazosin |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Cataflam DD® | Drug | Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions. |
|
| Apparent Volume of Distribution During Terminal Phase (Vz/f) of Diclofenac |
| Pre-dose up to 24 hours Post-dose |
| Apparent Total Body Clearance of Drug From Plasma (CL/f) of Diclofenac | Pre-dose up to 24 hours Post-dose |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to 15 days (end of study) |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Baseline up to 15 days (end of study) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Baseline up to 15 days (end of study) |
| Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) | Baseline up to 15 days (end of study) |