Bioequivalence of Pyronaridine Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet (SP-C-009-07)

This study has been completed.

Sponsor:

Collaborator:

Shin Poong Pharmaceuticals

Information provided by:

Medicines for Malaria Venture

ClinicalTrials.gov Identifier:

NCT00682630

First received: May 19, 2008

Last updated: January 21, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 19, 2008

Last Updated Date

January 21, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

July 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults. [ Time Frame: 85 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00682630 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the safety of the two formulations in relation to one another [ Time Frame: 85 days ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bioequivalence of Pyronaridine Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet

Official Title ^ICMJE

Bioequivalence Trial of Pyronaridine:Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet

Brief Summary

The objective of the study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Malaria

Intervention ^ICMJE

Drug: pyronaridine artesunate

720:240 mg of the reference tablet formulation; wash out period of 43 days; 720:240 mg of the to-be-marketed formulation; wash out period of 43 days

Study Arms

Experimental: Study Group 1
Study Period 1: Treatment A (clinical trial reference tablets) 43 Days wash out Study Period 2: Treatment B (to-be-marketed tablets) 43 Days follow-up

Intervention: Drug: pyronaridine artesunate
Experimental: Study Group 2
Study Period 1: Treatment B (to-be-marketed tablets) 43 Days wash out Study Period 2: Treatment A (clinical trial reference tablets). 43 Days follow-up

Intervention: Drug: pyronaridine artesunate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

July 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female subjects between the ages of 18 and 45 years with a body weight between 55 and 75 kg and a body mass index using Quetelet's Index - weight (kg)/height2 (m2) between 18-28
Signed and dated a written informed consent form before undergoing any study related activities, including discontinuation of any prohibited medications
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical investigator
Normal (or abnormal and clinically insignificant) laboratory values at screening

Exclusion Criteria:

Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 mseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 45 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00682630

Other Study ID Numbers ^ICMJE

SP-C-009-07

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Medical Director, Medicines for Malaria Venture

Study Sponsor ^ICMJE

Medicines for Malaria Venture

Collaborators ^ICMJE

Shin Poong Pharmaceuticals

Investigators ^ICMJE

Not Provided

PRS Account

Medicines for Malaria Venture

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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