Phase 1
Completed N=70
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
Intestinal Diseases
Source: ClinicalTrials.gov NCT06201559 ↗
Enrolled (actual)
70
Serious AEs
0.7%
Results posted
Jan 2025
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Albendazole — 43.846; 41.685; 39.737; 46.115 nanogram/millilitre (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Albendazole |
43.846; 41.685; 39.737; 46.115 | — |
| PRIMARY Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole |
179.419; 164.052; 161.034; 182.792 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide |
638.051; 644.730; 643.276; 710.382 | — |
| SECONDARY Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide |
6129.744; 6023.449; 6046.054; 6572.338 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide |
189.347; 174.979; 169.433; 192.388; 7372.856; 7189.644 | — |
| SECONDARY Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide |
3.31; 3.41; 3.39; 3.52; 4.64; 4.64 | — |
| SECONDARY Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide |
5.22; 5.53; 5.11; 5.62; 8.47; 8.20 | — |
| SECONDARY Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide |
0.133; 0.125; 0.136; 0.123; 0.082; 0.085 | — |
| SECONDARY Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide |
3.304; 3.241; 3.763; 3.275; 14.513; 13.726 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
7; 6 | — |
| SECONDARY Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic) |
76.1; 77.1; 74.8; 75.7; 74.6; 75.7 | — |
| SECONDARY Absolute Values of Vital Signs: Respiratory Rate |
15.5; 15.8; 17.0; 16.4; 16.5; 16.5 | — |
| SECONDARY Absolute Values of Vital Signs: Radial Pulse |
72.9; 74.2; 70.6; 70.4; 73.4; 72.9 | — |
| SECONDARY Change From Baseline in Vital Signs: Blood Pressure |
0.0; 0.0; -1.3; -1.4; -1.5; -1.4 | — |
| SECONDARY Change From Baseline in Vital Signs: Respiratory Rate |
-0.6; 0.2; 0.6; 0.4; 0.2; -0.0 | — |
| SECONDARY Change From Baseline in Vital Signs: Radial Pulse |
0.0; 0.0; -2.2; -3.8; 0.6; -1.3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06201559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.