Eletriptan Pharmacokinetics In Korean Males

Study Overview
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Brief Summary
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The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.

Official Title
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An Open Label, Single And Repeat Dose Randomized Crossover Study To Estimate The Pharmacokinetics And Safety Of Eletriptan Hydrobromide Tablets In Healthy Korean Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Eletriptan commercial tablet
* Drug: Eletriptan commercial tablet
* Drug: Eletriptan commercial tablet
* Drug: Eletriptan commercial tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subjects, 18-55 years old Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 provide informed consent Exclusion Criteria: blood pressure >140/90 mm Hg any condition possibly affecting drug absorption positive urine drug screen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>1 X 20 mg eletriptan | Drug: Eletriptan commercial tablet<br>* 20 mg tablet, single dose<br>|
| Experimental: Treatment B<br>1 X 40 mg eletriptan | Drug: Eletriptan commercial tablet<br>* 40 mg tablet, single dose of 1 X 40 mg<br>|
| Experimental: Treatment C<br>2 X 40 mg eletriptan | Drug: Eletriptan commercial tablet<br>* 40 mg tablet, single dose of 2 X 40 mg<br>|
| Experimental: Treatment D<br>1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose | Drug: Eletriptan commercial tablet<br>* 40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] | AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D) | 
| AUC From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast). | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) | 
| Maximum Observed Plasma Concentration (Cmax) |  | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) | 
| Plasma Decay Half Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetic, eletriptan, Korean, crossover