Healthy VolunteersPhase 4NCT00875030
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
A Phase 4 study testing artesunate sachets and Arsuamoon in people with Healthy Volunteers, run by Pfizer at 1 site in India.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- artesunate sachets and Arsuamoon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2009to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
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).
- Conditions
- Healthy Volunteers
- Being tested
- artesunate sachets, Arsuamoon
- Keywords
- Bioequivalence study-artesunate sachets-arsuamoon tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunate sachetsDrug
single dose 50 mg (2 X 25 mg) artesunate sachets
ArsuamoonDrug
single dose 50 mg arsuamoon tablet
| Study group | Role | What they receive |
|---|---|---|
| 1.0 | Experimental | Not described Receives: Drug: artesunate sachets |
| 2.0 | Active comparator | Not described Receives: Drug: Arsuamoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, AUCinf and AUClast, for DHA
Measured: 1 year
Secondary outcomes (2)
Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate.
Measured: 1 year
Safety laboratory tests, vital signs, and adverse events.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875030
- Sponsor's protocol ID
- B0551002
- Status last verified
- Jun 2010
- First submitted
- 2 Apr 2009
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00875030
- Acronym / sponsor ID
- B0551002
- Conditions
- Healthy Volunteers
- Keywords
- Bioequivalence study-artesunate sachets-arsuamoon tablet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.0 | Experimental | Drug: artesunate sachets |
| 2.0 | Active comparator | Drug: Arsuamoon |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| artesunate sachetssingle dose 50 mg (2 X 25 mg) artesunate sachets | Drug | 1.0 |
| Arsuamoonsingle dose 50 mg arsuamoon tablet | Drug | 2.0 |
Primary outcome
Cmax, AUCinf and AUClast, for DHA
Time frame: 1 year
2 secondary outcomes
Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate.
Time frame: 1 year
Safety laboratory tests, vital signs, and adverse events.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing artesunate sachets and Arsuamoon in people with Healthy Volunteers, run by Pfizer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax, AUCinf and AUClast, for DHA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.