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

NCT ID: NCT06201559

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2023-09-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Albendazole IP 400 mg

Intervention Type: DRUG

Albendazole IP 400 mg tablets will be administered under fed conditions

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.

Group Type: EXPERIMENTAL

Albendazole 400 mg

Intervention Type: DRUG

Albendazole 400 mg tablets will be administered under fed conditions

Interventions

Albendazole IP 400 mg

Albendazole IP 400 mg tablets will be administered under fed conditions

Intervention Type: DRUG

Albendazole 400 mg

Albendazole 400 mg tablets will be administered under fed conditions

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Ahmedabad, , India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

221030

Identifier Type: -

Identifier Source: org_study_id