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Study to Evaluate Multiple Doses of ERB-041 in Healthy, Female Japanese Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00434187
First received: February 9, 2007
Last updated: July 8, 2009
Last verified: July 2009
History of Changes
  Purpose

The primary objective is evaluate the safety, tolerability, and pharmacokinetics of multiple doses of ERB-041, an investigational drug, in healthy, female Japanese subjects.


Condition Intervention Phase
Healthy
 Drug: ERB-041
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Ascending Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics of ERB-041 Administered Orally to Healthy, Female Japanese Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • safety, pharmacokinetics

Estimated Enrollment: 24
Study Start Date: August 2006
Estimated Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of medical history and screening evaluations.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434187

Locations
Japan
Kan-nondai, Tsukuba-shi, Ibaraki, Japan, 305-0856
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00434187     History of Changes
Other Study ID Numbers: 3142A2-115
Study First Received: February 9, 2007
Last Updated: July 8, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy

ClinicalTrials.gov processed this record on May 19, 2013