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

Intestinal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06201559
• Other study ID #: 221030
• Status: Completed
• Phase: Phase 1
• Start date: August 21, 2023
• Est. completion date: September 12, 2023

Study information

• Verified date: December 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Diseases

Intervention

Drug:
• Albendazole IP 400 mg
Albendazole IP 400 mg tablets will be administered under fed conditions
• Albendazole 400 mg
Albendazole 400 mg tablets will be administered under fed conditions

Locations

Country	Name	City	State
India	Lambda Therapeutic Research Ltd	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of Albendazole		Up to 24 hours post dose
Primary	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	Maximum plasma concentration (Cmax) of Albendazole sulfoxide		Up to 24 hours post dose
Secondary	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
Secondary	Area under the plasma concentration-time curve extrapolated to infinity [AUC0-8] of Albendazole and Albendazole sulfoxide		Up to 24 hours post dose
Secondary	Time until Cmax is reached (Tmax) for Albendazole and Albendazole sulfoxide		Up to 24 hours post dose
Secondary	Plasma concentration half-life (t1/2) of Albendazole and Albendazole sulfoxide		Up to 24 hours post dose
Secondary	Lambda-z (?z) [Terminal elimination rate constant] of Albendazole and Albendazole sulfoxide		Up to 24 hours post dose
Secondary	AUC_% Extrap_obs (observed percentage of extrapolated area under concentration) for Albendazole and Albendazole sulfoxide		Up to 24 hours post dose
Secondary	Number of participants with adverse events (AE)		Up to 24 hours post dose
Secondary	Absolute values of vital signs: Blood pressure [millimeters of mercury (mmHg)		Up to 24 hours post dose
Secondary	Absolute values of vital signs: Respiratory rate [breaths per minute (bpm)		Up to 24 hours post dose
Secondary	Absolute values of vital signs: Radial pulse [beats per minute (bpm)		Up to 24 hours post dose
Secondary	Change from baseline in vital signs: Blood pressure [millimeters of mercury (mmHg)		Baseline (Day 1) and up to 24 hours post dose
Secondary	Change from baseline in vital signs: Respiratory rate [breaths per minute (bpm)		Baseline (Day 1) and up to 24 hours post dose
Secondary	Change from baseline in vital signs: Radial pulse [beats per minute (bpm)		Baseline (Day 1) and up to 24 hours post dose