Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Phase 1, Open-Label, Randomized, Single-Dose, 5-Way Crossover Pilot Bioavailability Study Comparing Eletriptan Oral Disintegrating Tablet Formulations A And B Administered With Or Without Water To Relpax® Commercial Tablets Administered With Water

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Commercial tablet with water
* Drug: ODT #1 without water
* Drug: ODT #2 without water
* Drug: ODT #1 with water
* Drug: ODT #2 with water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects No CYP3A4 inhibitors Exclusion Criteria: Clinically significant disease in any organ system Positive urine drug screen

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eletriptan commercial tablet with water<br>Eletriptan commercial tablet given with water | Drug: Commercial tablet with water<br>* 40 mg tablet, given once to each subject<br>|
| Experimental: Eletriptan oral disintegrating tablet (ODT) #1 without water<br>Oral disintegrating tablet formulation #1 without water | Drug: ODT #1 without water<br>* 40 mg tablet given once to each subject<br>|
| Experimental: Oral disintegrating tablet formulation (ODT) #2 without water<br>Oral disintegrating tablet formulation #2 without water | Drug: ODT #2 without water<br>* 40 mg tablet given once to each subject<br>|
| Experimental: Oral disintegrating tablet formulation (ODT) #1 with water<br>Oral disintegrating tablet formulation (ODT) #1 with water | Drug: ODT #1 with water<br>* 40 mg tablet given once to each subject<br>|
| Experimental: Oral disintegrating tablet formulation (ODT) #2 with water<br>Oral disintegrating tablet formulation (ODT) #2 with water | Drug: ODT #2 with water<br>* 40 mg tablet given once to each subject<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) |  | 24 hr | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, eletriptan, bioavailability, oral disintegrating tablet