Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions

Phase 1

Completed

Conditions: Intestinal Diseases

Interventions: Drug: Albendazole IP 400 mg
Drug: Albendazole 400 mg

Registration Number: NCT06201559

Lead Sponsor: GlaxoSmithKline

Brief Summary: The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

Inclusion Criteria

Healthy, non-smoker, adult participants having body mass index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kilogram (kg)/ height in meter square (m2)
Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead electrocardiogram (ECG) and X-ray chest (postero-anterior view) recordings.
Able to understand and adhere to the study procedures
Voluntary written informed consent is given for study participation
In case of female participants:

Surgically sterilized at least 6 months prior to study participation;Or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study, And Serum pregnancy test must be negative.

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaction to albendazole or any excipients or any related drug or any substance.
History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or non-steroidal anti inflammatory drugs (NSAIDs) induced urticaria.
History or presence of seizure or psychiatric disorders.
Ingestion of a medication (prescribed medication & over the counter (OTC) medication, herbal remedies, cimetidine, praziquantel, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital) at any time in 14 days prior to dosing and any vaccine (including COVID-19 vaccine) from 14 days prior to dosing. In any such case participant selection will be at the discretion of the Principal Investigator.
Receipt of an intervention or participation in a drug research study within a period of 90 days prior to the first dose of study intervention **.
- If intervention is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of intervention received.
A positive hepatitis screen including hepatitis B surface antigen and/or hepatitis C virus (HCV) antibodies.
A positive test result for HIV antibody (1 and/or 2).
The presence of clinically significant abnormal laboratory values during screening.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence TRTR	Albendazole IP 400 mg	Participants will be administered with test (T) intervention \[Albendazole Indian Pharmacopoeia (IP) 400 mg\] in Period 1, reference (R) intervention (Albendazole Tablets 400 mg) in Period 2, T intervention in Period 3 and R intervention in Period 4.
Sequence RTRT	Albendazole 400 mg	Participants will be administered with reference (R) intervention in Period 1, test (T) intervention in Period 2, R intervention in Period 3 and T intervention in Period 4.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Albendazole	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Up to 22 days	A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period	Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.
Absolute Values of Vital Signs: Respiratory Rate	At screening, after check-in and before check-out in each period (each period is of 1 day)	Respiratory rate was collected in sitting position.
Absolute Values of Vital Signs: Radial Pulse	At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period (each period is of 1 day)	Radial pulse was collected in sitting position.
Change From Baseline in Vital Signs: Blood Pressure	Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period	Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.
Change From Baseline in Vital Signs: Respiratory Rate	After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)	Respiratory rate was collected in sitting position.
Change From Baseline in Vital Signs: Radial Pulse	pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period	Radial pulse was collected in sitting position.