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

An Open Label, Balanced, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single Oral Dose, Full Replicate Crossover, Bioequivalence Study of Albendazole Tablets IP 400 mg of Biddle Sawyer Limited (GSK Group Company) With Albendazole Tablets 400 mg of Glaxo SmithKline Consumer Healthcare, South Africa (PTY) Ltd in Healthy, Adult Participants Under Fed Condition

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Diseases
• Intervention / Treatment: Drug: Albendazole IP 400 mg; Drug: Albendazole 400 mg

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 382481
      • Lambda Therapeutic Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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)
2. 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.
3. Able to understand and adhere to the study procedures
4. Voluntary written informed consent is given for study participation
5. 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:

1. Known hypersensitivity or idiosyncratic reaction to albendazole or any excipients or any related drug or any substance.
2. 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.
3. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or non-steroidal anti inflammatory drugs (NSAIDs) induced urticaria.
4. History or presence of seizure or psychiatric disorders.
5. 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.

6. 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.
7. A positive hepatitis screen including hepatitis B surface antigen and/or hepatitis C virus (HCV) antibodies.
8. A positive test result for HIV antibody (1 and/or 2).
9. The presence of clinically significant abnormal laboratory values during screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence TRTR; 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; Albendazole IP 400 mg tablets will be administered under fed conditions
Experimental: Sequence RTRT; 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; Albendazole 400 mg tablets will be administered under fed conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax) of Albendazole	Up to 24 hours post dose
Area under the plasma concentration curve from time 0 to the last measured [AUC(0-t)] for Albendazole	Up to 24 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax) of Albendazole sulfoxide	Up to 24 hours post dose
Area under the plasma concentration curve from time 0 to the last measured [AUC(0-t)] of Albendazole sulfoxide	Up to 24 hours post dose
Area under the plasma concentration-time curve extrapolated to infinity [AUC0-∞] of Albendazole and Albendazole sulfoxide	Up to 24 hours post dose
Time until Cmax is reached (Tmax) for Albendazole and Albendazole sulfoxide	Up to 24 hours post dose
Plasma concentration half-life (t1/2) of Albendazole and Albendazole sulfoxide	Up to 24 hours post dose
Lambda-z (λz) [Terminal elimination rate constant] of Albendazole and Albendazole sulfoxide	Up to 24 hours post dose
AUC_% Extrap_obs (observed percentage of extrapolated area under concentration) for Albendazole and Albendazole sulfoxide	Up to 24 hours post dose
Number of participants with adverse events (AE)	Up to 24 hours post dose
Absolute values of vital signs: Blood pressure [millimeters of mercury (mmHg)	Up to 24 hours post dose
Absolute values of vital signs: Respiratory rate [breaths per minute (bpm)	Up to 24 hours post dose
Absolute values of vital signs: Radial pulse [beats per minute (bpm)	Up to 24 hours post dose
Change from baseline in vital signs: Blood pressure [millimeters of mercury (mmHg)	Baseline (Day 1) and up to 24 hours post dose
Change from baseline in vital signs: Respiratory rate [breaths per minute (bpm)	Baseline (Day 1) and up to 24 hours post dose
Change from baseline in vital signs: Radial pulse [beats per minute (bpm)	Baseline (Day 1) and up to 24 hours post dose

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Estimated): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bioequivalence; Albendazole
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Albendazole
• Other Study ID Numbers: 221030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No