HelminthiasisPhase 1NCT01755637

Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

A Phase 1 study testing Albendazole in people with Helminthiasis, run by GlaxoSmithKline at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males. Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Helminthiasis
What is being tested?: Albendazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 2 sitesChina
Study dates: Apr 2012to Jun 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male aged from 18 years up to 40 years (inclusive).
Body mass index within the range of 19-24kg/m^2.
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Negative for serum hepatitis B surface antigen, hepatitis C antibody and antibody of HIV.

Who cannot join

Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Substance abuse: Recent history (within the last year) of alcohol or other substance abuse or failed to pass drugs of abuse screen and/or alcohol screen test.
Disease
Current or recurrent disease that could affect the action, absorption or distribution of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, abnormal liver function tests, renal insufficiency, congestive heart failure);
Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures;
History of gastrointestinal bleeding or peptic ulcer;

Show all 17Show fewer

Asthma
History of liver disease
Medication
Use of any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing
Current or regular use of any prescription or over-the-counter medication, any other ABZ containing products, and traditional Chinese medicine.
Smoking
Subjects who are current smokers or non-smokers of less than 3 months;
Prior (within seven days of dosing) or current use of any other nicotine containing products, including nicotine replacement therapy.
Blood
Blood donation ≥ 500 ml within 90 days before the first study session.
Plasma donation within the 90 days before the first study session.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Central Hospital of China Aerospace Corporation
Beijing, Beijing Municipality, 100049
Tongji Hospital, Medical College Huazhong
Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: A Single-dose, Two-centre, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Two Kinds of AlbendazoleTablet Formulations in Healthy Chinese Adult Males

The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males.

Read the detailed description

Due to the product manufacture process change in Albendazole oral formulation from ethanol based granulation process to aqua based granulation process, State Food and Drug Administration officially requested Tianjin Smith Kline and French Laboratories to carry out a Bioequivalence study to demonstrate bioequivalence between the manufacturing processes. This trial will be conducted to support the official requirement via the comparison of the pharmacokinetic profiles between both the drugs manufactured under the different processes.

After oral administration, Albendazole is quickly oxidized into its pharmacologically active metabolite, Albendazole sulphoxide (ABZ-SO. Due to extensive metabolism and limited absorption, plasma concentration of ABZ after oral administration was found to be too low to be measured. Thus, this trial will also compare the pharmacokinetic profiles of ABZ-SO manufactured using different solvents.

Conditions: Helminthiasis
Being tested: Albendazole
Medical subject headings: Helminthiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlbendazoleDrug
Albendazole tablets 400 mg

Study groups in NCT01755637
Study group	Role	What they receive
Albendazole tablet (Aqua Based)	Experimental	Albendazole tablets 400 milligram (mg) manufactured under aqua based solvent condition taken orally with 200 millilitre (mL) of water as single dose treatment. Receives: Drug: Albendazole
Albendazole tablet (Alcohol Based)	Active comparator	Albendazole tablets 400 mg manufactured under ethanol based solvent condition taken orally with 200 mL of water as single dose treatment. Receives: Drug: Albendazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.
AUC (0-t) was evaluated using the trapezoid rule.
Measured: Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
AUC [0-infinity (Inf)] of Albendazole
AUC (0-inf) was evaluated using the trapezoid rule.
Measured: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole
Cmax was depicted from plasma concentration of Albendazole.
Measured: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr

Secondary outcomes (4)

Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole
Tmax was time at which Cmax of Albendazole was reached.
Measured: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
AUC (0-t) of Active Metabolite - Albendazole Sulphoxide
AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.
Measured: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide
AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.
Measured: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
Cmax of Active Metabolite - Albendazole Sulphoxide
Cmax was depicted from plasma concentration of Albendazole.
Measured: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jun 2012

First posted24 Dec 2012 (estimated)
Study startApr 2012
Primary completionApr 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HelminthiasisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01755637
Sponsor's protocol ID: O7921353
Status last verified: May 2013
First submitted: 19 Dec 2012
Last updated: 15 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Helminthiasis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose, Two-centre, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Two Kinds of AlbendazoleTablet Formulations in Healthy Chinese Adult Males
ClinicalTrials.gov ID: NCT01755637
Acronym / sponsor ID: O7921353
Conditions: Helminthiasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Apr 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 24 Dec 2012 (estimated)
Results: Posted 15 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Albendazole tablet (Aqua Based)	Experimental	Drug: AlbendazoleAlbendazole tablets 400 milligram (mg) manufactured under aqua based solvent condition taken orally with 200 millilitre (mL) of water as single dose treatment.
Albendazole tablet (Alcohol Based)	Active comparator	Drug: AlbendazoleAlbendazole tablets 400 mg manufactured under ethanol based solvent condition taken orally with 200 mL of water as single dose treatment.

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male aged from 18 years up to 40 years (inclusive).
Body mass index within the range of 19-24kg/m^2.
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Negative for serum hepatitis B surface antigen, hepatitis C antibody and antibody of HIV.

Key exclusion criteria (17 listed)

Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Substance abuse: Recent history (within the last year) of alcohol or other substance abuse or failed to pass drugs of abuse screen and/or alcohol screen test.
Disease
Medication
Smoking

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
AlbendazoleAlbendazole tablets 400 mg	Drug	Albendazole tablet (Alcohol Based), Albendazole tablet (Aqua Based)

Primary outcome

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.
Time frame: Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
AUC (0-t) was evaluated using the trapezoid rule.
AUC [0-infinity (Inf)] of Albendazole
Time frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
AUC (0-inf) was evaluated using the trapezoid rule.
Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole
Time frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
Cmax was depicted from plasma concentration of Albendazole.

4 secondary outcomes

Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole
Time frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
AUC (0-t) of Active Metabolite - Albendazole Sulphoxide
Time frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide
Time frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr
Cmax of Active Metabolite - Albendazole Sulphoxide
Time frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr

Results and safety

Results posted to the registry on 15 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Albendazole (Aqua) First, Then Albendazole (Alcohol)	28	28
Albendazole (Alcohol) First, Then Albendazole (Aqua)	28	27

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.

Time frame: Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr. Mean (Standard Deviation). Unit: nanogram (ng).hr per milliliter (mL)

Measure	Experimental: Albendazole Tablet (Aqua Based) n = 55	Reference: Albendazole Tablet (Alcohol Based) n = 55
Value	54.82 (51.56)	48.07 (49.22)

Experimental: Albendazole Tablet (Aqua Based) vs Reference: Albendazole Tablet (Alcohol Based): Geometric mean Ratio of treatments: 114.37 (90% CI 100.49 to 130.16)

Population analysed: The analysis was carried out per protocol population. Missing data was not imputed for evaluation.

Primary outcome: AUC [0-infinity (Inf)] of Albendazole

Time frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr. Mean (Standard Deviation). Unit: ng.hr/mL

Measure	Experimental: Albendazole Tablet (Aqua Based) n = 19	Reference: Albendazole Tablet (Alcohol Based) n = 16
Value	69.55 (80.44)	67.19 (84.74)

Experimental: Albendazole Tablet (Aqua Based) vs Reference: Albendazole Tablet (Alcohol Based): Geometric mean ratio of treatments: 107.41 (90% CI 69.03 to 167.13)

Population analysed: The analysis was carried out per protocol population. Missing data was not imputed for evaluation.

Primary outcome: Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole

Time frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr. Mean (Standard Deviation). Unit: ng/mL

Measure	Experimental: Albendazole Tablet (Aqua Based) n = 55	Reference: Albendazole Tablet (Alcohol Based) n = 56
Value	14.76 (15.88)	14.58 (16.93)

Experimental: Albendazole Tablet (Aqua Based) vs Reference: Albendazole Tablet (Alcohol Based): Geometric mean ratio of treatments: 111.28 (90% CI 94.76 to 130.68)

Population analysed: The analysis was carried out per protocol population. Missing data was not imputed for evaluation.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Albendazole Tablet (Aqua Based)	0 of 55 (0%)	1 of 55 (1.8%)	Not reported
Albendazole Tablet (Alcohol Based)	0 of 56 (0%)	4 of 56 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Helminthiasis

RecruitingObservational study
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection
Malaria, Intestinal Worms
Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
Not yet recruitingPhase 3
Follow-up Assessment of Change in Soil-transmitted Helminths Infection Intensity in Uganda
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RecruitingPhase 3
Better Options for Lymphatic Filariasis Treatment
Lymphatic Filariasis, Scabies

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.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Albendazole in people with Helminthiasis, run by GlaxoSmithKline at 2 sites in China.

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 4 inclusion and 17 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 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole. (time frame: Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01755637.

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 15 Jul 2013.