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

221030

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.

2023-08-21

2023-09-12

2023-09-12

Completed

Early phase I

70

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

2024-01-11