Eletriptan Pharmacokinetics In Korean Males
- Registration Number
- NCT01139515
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment D Eletriptan commercial tablet 1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose Treatment B Eletriptan commercial tablet 1 X 40 mg eletriptan Treatment C Eletriptan commercial tablet 2 X 40 mg eletriptan Treatment A Eletriptan commercial tablet 1 X 20 mg eletriptan
- Primary Outcome Measures
Name Time Method AUC From Time Zero to Last Quantifiable 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) Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] 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 (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-∞).
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
Name Time Method 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) 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 is the time measured for the plasma concentration to decrease by one half.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇰🇷Seoul, Korea, Republic of