Clinical trial NCT06201559: Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intestinal Diseases
Keywords: Albendazole
Bioequivalence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Albendazole
timeFrame: 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
measure: Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole
timeFrame: 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:
measure: Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide
timeFrame: 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
measure: Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide
timeFrame: 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
measure: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide
timeFrame: 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
measure: Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide
timeFrame: 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
measure: Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide
timeFrame: 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
measure: Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide
timeFrame: 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
measure: Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide
timeFrame: 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
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 22 days
measure: Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
timeFrame: At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period
measure: Absolute Values of Vital Signs: Respiratory Rate
timeFrame: At screening, after check-in and before check-out in each period (each period is of 1 day)
measure: Absolute Values of Vital Signs: Radial Pulse
timeFrame: At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period (each period is of 1 day)
measure: Change From Baseline in Vital Signs: Blood Pressure
timeFrame: Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period
measure: Change From Baseline in Vital Signs: Respiratory Rate
timeFrame: After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)
measure: Change From Baseline in Vital Signs: Radial Pulse
timeFrame: pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: GSK Investigational Site
Study officials:
References: