Bioequivalence Study Comparing Artesunate Tablet To Arsua... | NCT00894374

Studies
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

NCT00894374

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jun 25, 2010Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Falciparum Malaria

Interventions

Artesunate (Test)
Artesunate (Comparator)

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

May 4, 2009

First Submission Date that Met QC Criteria

May 5, 2009

First Posted Date

May 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2010

Last Update Posted Date

Jun 25, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Artesunate (Pfizer)	Experimental		Drug: Artesunate (Test)
Artesunate (Arsuamoon® Tablets Guilin-China)	Active Comparator		Drug: Artesunate (Comparator)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Artesunate (Test)	Drug	Oral tablet, single dose, 1 x 100 mg	Artesunate (Pfizer)

Measure	Description	Time Frame
AUC and Cmax of active metabolite of artesunate		30-Aug-2009

Measure	Description	Time Frame
Tolerability		30-Aug-2009

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Singapore	Singapore	188770	Singapore

References Module

Citations

Not provided

ID	Term
D008288	Malaria
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections

ID	Term
D037621	Artemisinins
D017382	Reactive Oxygen Species
D005609	Free Radicals
D007287	Inorganic Chemicals