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

April 16, 2020 updated by: Medicines for Malaria Venture

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Arzo, Switzerland, 6864
        • CROSS Research S.A., Phase I Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Signed and dated a written informed consent form before undergoing any study related activities, including discontinuation of any prohibited medications
  3. Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical investigator
  4. Normal (or abnormal and clinically insignificant) laboratory values at screening

Exclusion Criteria:

  1. 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)
  2. Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
85 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicines for Malaria Venture

Collaborators

Shin Poong Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 21, 2008

First Posted (Estimate)

May 22, 2008

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP-C-009-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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