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

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ClinicalTrials.gov Identifier: NCT00434187
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: ERB-041 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : August 2006
Study Completion Date : October 2006



Primary Outcome Measures :
  1. safety, pharmacokinetics


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00434187     History of Changes
Other Study ID Numbers: 3142A2-115
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009

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