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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole | Drug | Albendazole tablets 400 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole | Tmax was time at which Cmax of Albendazole was reached. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
Blood
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital of China Aerospace Corporation | Beijing | Beijing Municipality | 100049 | China | ||
| Tongji Hospital, Medical College Huazhong |
Out of 123 screened participants, 54 did not meet the study criteria; 12 withdrew consent and one was lost to follow -up. Only 56 participants were randomized.
Study was conducted at two clinical sites in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Albendazole (Aqua) First, Then Albendazole (Alcohol) | Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment, followed by single dose treatment of 400 mg albendazole tablets manufactured under ethanol based solvent conditions. A wash-out period of 7 days was maintained between treatment periods. |
| FG001 | Albendazole (Alcohol) First, Then Albendazole (Aqua) | Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment followed by 400 mg aqua based albendazole tablets. A wash-out period of 7 days was maintained between treatment periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were evaluated for baseline measures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was carried out per protocol population. Missing data was not imputed for evaluation. | Posted | Mean | Standard Deviation | nanogram (ng).hr per milliliter (mL) | 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 |
|
Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albendazole Tablet (Aqua Based) | Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006373 | Helminthiasis |
| ID | Term |
|---|---|
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule. |
| 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. | 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. | 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 |
| Wuhan |
| Hubei |
| 430030 |
| China |
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment. |
|
|
|
| Primary | AUC [0-infinity (Inf)] of Albendazole | AUC (0-inf) was evaluated using the trapezoid rule. | The analysis was carried out per protocol population. Missing data was not imputed for evaluation. | Posted | Mean | Standard Deviation | ng.hr/mL | 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 |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole | Cmax was depicted from plasma concentration of Albendazole. | The analysis was carried out per protocol population. Missing data was not imputed for evaluation. | Posted | Mean | Standard Deviation | ng/mL | 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 | Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole | Tmax was time at which Cmax of Albendazole was reached. | The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax. | Posted | Median | Full Range | hr | 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 | AUC (0-t) of Active Metabolite - Albendazole Sulphoxide | AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule. | The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax. | Posted | Mean | Standard Deviation | ng.hr/mL | 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 | AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide | AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule. | The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax. | Posted | Mean | Standard Deviation | ng.hr/mL | 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 | Cmax of Active Metabolite - Albendazole Sulphoxide | Cmax was depicted from plasma concentration of Albendazole. | The analysis was carried out per protocol population. Missing data was not imputed for evaluation. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
|
|
|
| 0 |
| 55 |
| 1 |
| 55 |
| EG001 | Albendazole Tablet (Alcohol Based) | Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment. | 0 | 56 | 4 | 56 |
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Gamma-Glutamyl Transferase Increased | Investigations | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Albuminuria | Renal and urinary disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |