A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00875030
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: artesunate sachets; Drug: Arsuamoon	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1.0	Drug: artesunate sachets; single dose 50 mg (2 X 25 mg) artesunate sachets
Active Comparator: 2.0	Drug: Arsuamoon; single dose 50 mg arsuamoon tablet

Outcome Measures

Primary Outcome Measures

1. Cmax, AUCinf and AUClast, for DHA [1 year]

Secondary Outcome Measures

1. Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate. [1 year]

2. Safety laboratory tests, vital signs, and adverse events. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Navi Mumbai	Maharashtra	India	400709

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00875030
• Other Study ID Numbers: B0551002
• First Posted: Apr 3, 2009
• Last Update Posted: Jun 9, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: Bioequivalence study-artesunate sachets-arsuamoon tablet
• Additional relevant MeSH terms: Artesunate

Study Results

No Results Posted as of Jun 9, 2010