Eletriptan Pharmacokinetics In Korean Males

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Eletriptan commercial tablet; Drug: Eletriptan commercial tablet; Drug: Eletriptan commercial tablet; Drug: Eletriptan commercial tablet

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 7, 2010
• First Posted (Estimate): June 8, 2010

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: pharmacokinetic; crossover; Korean; eletriptan
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Eletriptan
• Other Study ID Numbers: A1601126