Status:
COMPLETED
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
Lead Sponsor:
GlaxoSmithKline
Conditions:
Intestinal Diseases
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06201559
Start Date
August 21 2023
End Date
September 12 2023
Last Update
January 27 2025
Active Locations (1)
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1
GSK Investigational Site
Ahmedabad, India, 382481