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

NCT06201559 | Completed Phase 1 Results DMC

• 1 other identifier: 221030
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Diseases

Keywords

Albendazole; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of Albendazole

  Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.

  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

• Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole

  Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.

  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

Secondary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Sequence TRTR

EXPERIMENTAL

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.

Drug: Albendazole IP 400 mg

Sequence RTRT

EXPERIMENTAL

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.

Drug: Albendazole 400 mg

Interventions

Albendazole IP 400 mg DRUG

Albendazole IP 400 mg tablets will be administered under fed conditions

Sequence TRTR

Albendazole 400 mg DRUG

Albendazole 400 mg tablets will be administered under fed conditions

Sequence RTRT

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ahmedabad, 382481, India

Location

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: August 21, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

IN (1)