NCT00875030

Brief Summary

The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_4 healthy-volunteers

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 9, 2010

Status Verified

June 1, 2010

Enrollment Period

Same day

First QC Date

April 2, 2009

Last Update Submit

June 7, 2010

Conditions

Healthy Volunteers

Keywords

Bioequivalence study-artesunate sachets-arsuamoon tablet

Outcome Measures

Primary Outcomes (1)

  • Cmax, AUCinf and AUClast, for DHA

    1 year

Secondary Outcomes (2)

  • Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate.

    1 year

  • Safety laboratory tests, vital signs, and adverse events.

    1 year

Study Arms (2)

1.0

EXPERIMENTAL
Drug: artesunate sachets

2.0

ACTIVE COMPARATOR
Drug: Arsuamoon

Interventions

artesunate sachetsDRUG

single dose 50 mg (2 X 25 mg) artesunate sachets

1.0
ArsuamoonDRUG

single dose 50 mg arsuamoon tablet

2.0

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (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.

You may not qualify if:

  • Any condition possibly affecting drug absorption.
  • A positive urine drug screen.
  • Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to artesunate or its derivatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Navi Mumbai, Maharashtra, 400709, India

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 9, 2010

Record last verified: 2010-06

Locations

IN(1)