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OpenTrials
Completed

NCT Number: NCT06201559

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

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.

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Key information

Conditions

Intestinal Diseases Digestive System Diseases Gastrointestinal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Ahmedabad, 382481, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Albendazole IP 400 mg

Drug

Albendazole IP 400 mg tablets will be administered under fed conditions

Albendazole 400 mg

Drug

Albendazole 400 mg tablets will be administered under fed conditions

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Albendazole

    Time frame: 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

    Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.

  2. Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole

    Time frame: 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

    Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide

    Time frame: 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

    Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

  2. Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide

    Time frame: 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

    Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

  3. Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide

    Time frame: 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

    Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

  4. Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide

    Time frame: 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

    Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

  5. Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide

    Time frame: 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

    Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

  6. Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide

    Time frame: 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

    Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

  7. Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide

    Time frame: 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

    Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

  8. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 22 days

    A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

  9. Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)

    Time frame: At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period

    Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.

  10. Absolute Values of Vital Signs: Respiratory Rate

    Time frame: At screening, after check-in and before check-out in each period (each period is of 1 day)

    Respiratory rate was collected in sitting position.

  11. Absolute Values of Vital Signs: Radial Pulse

    Time frame: 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)

    Radial pulse was collected in sitting position.

  12. Change From Baseline in Vital Signs: Blood Pressure

    Time frame: Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period

    Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.

  13. Change From Baseline in Vital Signs: Respiratory Rate

    Time frame: After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)

    Respiratory rate was collected in sitting position.

  14. Change From Baseline in Vital Signs: Radial Pulse

    Time frame: pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period

    Radial pulse was collected in sitting position.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2024
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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