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Eletriptan Pharmacokinetics In Korean Males

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Eletriptan commercial tablet (Drug); Eletriptan commercial tablet (Drug); Eletriptan commercial tablet (Drug); Eletriptan commercial tablet (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

AUC From Time Zero to Last Quantifiable Concentration (AUClast)

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Plasma Decay Half Life (t1/2)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of
Additional Information

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

Starting date: July 2010
Last updated: June 13, 2011

Page last updated: August 23, 2015

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