SP-C-009-07: Bioequivalence of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet

Sponsor

Medicines for Malaria Venture (Other)

Overall Status

Completed

CT.gov ID

NCT00682630

Collaborator

Shin Poong Pharmaceuticals (Industry)

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: pyronaridine artesunate	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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	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
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	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

Arm

Intervention/Treatment

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

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

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

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

Outcome Measures

Primary Outcome Measures

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. [85 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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