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The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eletriptan commercial tablet with water | Active Comparator | Eletriptan commercial tablet given with water |
|
| Eletriptan oral disintegrating tablet (ODT) #1 without water | Experimental | Oral disintegrating tablet formulation #1 without water |
|
| Oral disintegrating tablet formulation (ODT) #2 without water | Experimental | Oral disintegrating tablet formulation #2 without water |
|
| Oral disintegrating tablet formulation (ODT) #1 with water | Experimental | Oral disintegrating tablet formulation (ODT) #1 with water |
|
| Oral disintegrating tablet formulation (ODT) #2 with water | Experimental | Oral disintegrating tablet formulation (ODT) #2 with water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial tablet with water | Drug | 40 mg tablet, given once to each subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) | 24 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Time of peak eletriptan concentrations (Tmax), half life | 24 hr | |
| Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ODT #1 without water | Drug | 40 mg tablet given once to each subject |
|
| ODT #2 without water | Drug | 40 mg tablet given once to each subject |
|
| ODT #1 with water | Drug | 40 mg tablet given once to each subject |
|
| ODT #2 with water | Drug | 40 mg tablet given once to each subject |
|
| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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