A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects

• ClinicalTrials.gov Identifier: NCT00894660
• Recruitment Status: Completed
• First Posted: May 7, 2009
• Last Update Posted: April 21, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: May 4, 2009
• First Posted Date: May 7, 2009
• Last Update Posted Date: April 21, 2010
• Study Start Date: June 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 20, 2010): AUC and Cmax of amodiaquine [ Time Frame: 1 month ]
• Original Primary Outcome Measures (submitted: May 5, 2009): AUC and Cmax of amodiaquine [ Time Frame: 30-Sept-2009 ]
• Current Secondary Outcome Measures (submitted: April 20, 2010): Tolerability [ Time Frame: 1 month ]
• Original Secondary Outcome Measures (submitted: May 5, 2009): 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: A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Falciparum Malaria

Intervention

• Drug: Amodiaquine (Test)
  Oral tablet, single dose, 1 X 300 MG
  Other Name: Camoquin
• Drug: Amodiaquine (Comparator)
  Oral tablet, single dose, 2 X 150 MG
  Other Name: Camoquin

Study Arms

• Experimental: Amodiaquine (Pfizer)
  Intervention: Drug: Amodiaquine (Test)
• Active Comparator: Amodiaquine tablets (Arsuamoon-Guilin China)
  Intervention: Drug: Amodiaquine (Comparator)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2009): 38
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
• BMI of 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs).
• An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

• Evidence or history of clinically significant abnormalities.
• A positive urine drug screen, history of regular alcohol consumption.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT00894660
• Other Study ID Numbers: B0731004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2010