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To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé & PEPCID® (Famotidine) 20mg Tablets, USP.
An open-label, randomized, single dose, two-treatment, two-period, two-sequence, crossover bioequivalence with a washout period of at least 7 days between doses Healthy mixed skin Arab & Mediterranean Subjects ages between 18 and 45 years, body-mass index 18.5 to 30.0 kg/m2 inclusive, non-smokers or light smokers (smokers of not more than 10 cigarettes per day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET | Experimental | FLURBIPROFEN, FAMOTIDINE 100/20 mg MULTI-LAYER TABLET one tablet, once |
|
| ANTADYS® and PEPCID® | Active Comparator | ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET | Drug | MULTI-LAYER TABLET |
|
| Measure | Description | Time Frame |
|---|---|---|
| cmax | Cmax Ratio: The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on Flurbiprofen and Famotidine. AUC Ratio: The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on Flurbiprofen and Famotidine. | five weeks |
| tmax | three weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Rana T. Bustami, Ph.D. of Pharmacy | PRU | Principal Investigator |
| Dr. Rana T. Bustami, Ph.D. of Pharmacy | Dr. Rana T. Bustami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit | Amman | 00962 | Jordan |
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| ANTADYS® 100 mg, PEPCID® 20 mg | Drug | ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once |
|
|
| ID | Term |
|---|---|
| D005480 | Flurbiprofen |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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