Trial Outcomes & Findings for Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population (NCT NCT01755637)

NCT ID: NCT01755637

Last Updated: 2013-07-15

Results Overview

AUC (0-t) was evaluated using the trapezoid rule.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 56 participants
• Primary outcome timeframe: 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
• Results posted on: 2013-07-15

Participant Flow

Study was conducted at two clinical sites in China.

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.

Participant milestones

Measure	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.	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.
Period 1 STARTED	28	28
Period 1 COMPLETED	28	27
Period 1 NOT COMPLETED	0	1
Period 2 STARTED	28	27
Period 2 COMPLETED	28	27
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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.	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.
Period 1 Adverse Event	0	1

Baseline Characteristics

Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

Baseline characteristics by cohort

Measure	All Randomized Participants n=56 Participants All randomized participants were evaluated for baseline measures
Age Continuous	24.21 Years STANDARD_DEVIATION 2.715 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

AUC (0-t) was evaluated using the trapezoid rule.

Outcome measures

Measure	Experimental: Albendazole Tablet (Aqua Based) n=55 Participants Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.	Reference: Albendazole Tablet (Alcohol Based) n=55 Participants Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.	54.82 nanogram (ng).hr per milliliter (mL) Standard Deviation 51.56	48.07 nanogram (ng).hr per milliliter (mL) Standard Deviation 49.22

PRIMARY outcome

Timeframe: 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

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

AUC (0-inf) was evaluated using the trapezoid rule.

Outcome measures

Measure	Experimental: Albendazole Tablet (Aqua Based) n=19 Participants Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.	Reference: Albendazole Tablet (Alcohol Based) n=16 Participants Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
AUC [0-infinity (Inf)] of Albendazole	69.55 ng.hr/mL Standard Deviation 80.44	67.19 ng.hr/mL Standard Deviation 84.74

PRIMARY outcome

Timeframe: 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

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

Cmax was depicted from plasma concentration of Albendazole.

Outcome measures

Measure	Experimental: Albendazole Tablet (Aqua Based) n=55 Participants Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.	Reference: Albendazole Tablet (Alcohol Based) n=56 Participants Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole	14.76 ng/mL Standard Deviation 15.88	14.58 ng/mL Standard Deviation 16.93

SECONDARY outcome

Timeframe: 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

Population: The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.

Tmax was time at which Cmax of Albendazole was reached.

Outcome measures

Measure	Experimental: Albendazole Tablet (Aqua Based) n=55 Participants Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.	Reference: Albendazole Tablet (Alcohol Based) n=56 Participants Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole	1.50 hr Interval 0.5 to 4.0	1.00 hr Interval 0.5 to 3.0

SECONDARY outcome

Timeframe: 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

Population: The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.

AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.

Outcome measures

Measure	Experimental: Albendazole Tablet (Aqua Based) n=55 Participants Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.	Reference: Albendazole Tablet (Alcohol Based) n=55 Participants Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
AUC (0-t) of Active Metabolite - Albendazole Sulphoxide	2563.90 ng.hr/mL Standard Deviation 1108.19	2290.14 ng.hr/mL Standard Deviation 944.72

SECONDARY outcome

Timeframe: 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

Population: The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.

AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.

Outcome measures

Measure	Experimental: Albendazole Tablet (Aqua Based) n=43 Participants Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.	Reference: Albendazole Tablet (Alcohol Based) n=45 Participants Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide	3263.88 ng.hr/mL Standard Deviation 1456.41	2829.77 ng.hr/mL Standard Deviation 1128.06

SECONDARY outcome

Timeframe: 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

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

Cmax was depicted from plasma concentration of Albendazole.

Outcome measures

Measure	Experimental: Albendazole Tablet (Aqua Based) n=55 Participants Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.	Reference: Albendazole Tablet (Alcohol Based) n=56 Participants Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
Cmax of Active Metabolite - Albendazole Sulphoxide	221.45 ng/mL Standard Deviation 105.87	199.99 ng/mL Standard Deviation 108.89

Adverse Events

Albendazole Tablet (Aqua Based)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Albendazole Tablet (Alcohol Based)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Albendazole Tablet (Aqua Based) n=55 participants at risk Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.	Albendazole Tablet (Alcohol Based) n=56 participants at risk Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/55 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.	1.8% 1/56 • Number of events 1 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.
Infections and infestations Urinary Tract Infection	1.8% 1/55 • Number of events 1 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.	0.00% 0/56 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.
Investigations Gamma-Glutamyl Transferase Increased	0.00% 0/55 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.	1.8% 1/56 • Number of events 1 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/55 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.	1.8% 1/56 • Number of events 1 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.
Renal and urinary disorders Albuminuria	0.00% 0/55 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.	1.8% 1/56 • Number of events 1 • Adverse Events were collected from the first dosage of the session one, and until 5 days following last administration of the investigational product.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER