Trial record 1 of 1 for:
NCT00894660
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
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ClinicalTrials.gov Identifier: NCT00894660 |
Recruitment Status :
Completed
First Posted : May 7, 2009
Last Update Posted : April 21, 2010
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Sponsor:
Pfizer
Information provided by:
Pfizer
Tracking Information | ||||
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First Submitted Date ICMJE | May 4, 2009 | |||
First Posted Date ICMJE | May 7, 2009 | |||
Last Update Posted Date | April 21, 2010 | |||
Study Start Date ICMJE | June 2009 | |||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
AUC and Cmax of amodiaquine [ Time Frame: 1 month ] | |||
Original Primary Outcome Measures ICMJE |
AUC and Cmax of amodiaquine [ Time Frame: 30-Sept-2009 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Tolerability [ Time Frame: 1 month ] | |||
Original Secondary Outcome Measures ICMJE |
Adverse Events [ Time Frame: 30-Sept-2009 ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects | |||
Official Title ICMJE | A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects | |||
Brief Summary | The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Falciparum Malaria | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
38 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2009 | |||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Singapore | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00894660 | |||
Other Study ID Numbers ICMJE | B0731004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |