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
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