Phase 1
N=16
Eletriptan Pharmacokinetics In Korean Males
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01139515 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] — 291.3; 575.6; 1282.0; 1278.0 ng* hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Eletriptan commercial tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] |
291.3; 575.6; 1282.0; 1278.0 | — |
| PRIMARY AUC From Time Zero to Last Quantifiable Concentration (AUClast) |
281.2; 558.7; 1243.0; 1244.0 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
46.50; 94.72; 200.10; 183.60 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.750; 0.750; 0.750; 5.000 | — |
| SECONDARY Plasma Decay Half Life (t1/2) |
4.924; 4.630; 4.576; 4.753 | — |
Summary
The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01139515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.