Eletriptan Pharmacokinetics In Korean Males

NCT01139515 | Completed Phase 1 Results

• 1 other identifier: A1601126
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

pharmacokinetic; eletriptan; Korean; crossover

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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)

Study Arms (4)

Treatment A

EXPERIMENTAL

1 X 20 mg eletriptan

Drug: Eletriptan commercial tablet

Treatment B

EXPERIMENTAL

1 X 40 mg eletriptan

Drug: Eletriptan commercial tablet

Treatment C

EXPERIMENTAL

2 X 40 mg eletriptan

Drug: Eletriptan commercial tablet

Treatment D

EXPERIMENTAL

1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose

Drug: Eletriptan commercial tablet

Interventions

Eletriptan commercial tablet DRUG

20 mg tablet, single dose

Treatment A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male subjects, 18-55 years old
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
• provide informed consent

You may not qualify if:

• blood pressure \>140/90 mm Hg
• any condition possibly affecting drug absorption
• positive urine drug screen

Sponsors & Collaborators

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

Study Sites (1)

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Related Links

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 8, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 28, 2021
• Results First Posted: July 12, 2011

Record last verified: 2021-01

Locations

KR (1)