Intestinal DiseasesPhase 1NCT06201559

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

A Phase 1 study testing Albendazole IP 400 mg and Albendazole 400 mg in people with Intestinal Diseases, run by GlaxoSmithKline at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Intestinal Diseases
What is being tested?: Albendazole IP 400 mg and Albendazole 400 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteIndia
Study dates: 21 Aug 2023to 12 Sep 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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 **.

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

India1 site

GSK Investigational Site
Ahmedabad, 382481

Other trials in India

About this study

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

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.

Conditions: Intestinal Diseases
Being tested: Albendazole IP 400 mg, Albendazole 400 mg
Keywords: Albendazole, Bioequivalence
Medical subject headings: Intestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Albendazole IP 400 mgDrug
Albendazole IP 400 mg tablets will be administered under fed conditions
Albendazole 400 mgDrug
Albendazole 400 mg tablets will be administered under fed conditions

Study groups in NCT06201559
Study group	Role	What they receive
Sequence TRTR	Experimental	Participants will be administered with test (T) intervention [Albendazole Indian Pharmacopoeia (IP) 400 mg] in Period 1, reference (R) intervention (Albendazole Tablets 400 mg) in Period 2, T intervention in Period 3 and R intervention in Period 4. Receives: Drug: Albendazole IP 400 mg
Sequence RTRT	Experimental	Participants will be administered with reference (R) intervention in Period 1, test (T) intervention in Period 2, R intervention in Period 3 and T intervention in Period 4. Receives: Drug: Albendazole 400 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) of Albendazole
Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
Measured: 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
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole
Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
Measured: 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 (14)

Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide
Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Measured: 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
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide
Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Measured: 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
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Measured: 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
Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Measured: 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
Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Measured: 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
Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Measured: 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
Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Measured: 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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to 22 days
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.
Measured: At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period
Absolute Values of Vital Signs: Respiratory Rate
Respiratory rate was collected in sitting position.
Measured: At screening, after check-in and before check-out in each period (each period is of 1 day)
Absolute Values of Vital Signs: Radial Pulse
Radial pulse was collected in sitting position.
Measured: 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)
Change From Baseline in Vital Signs: Blood Pressure
Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.
Measured: Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period
Change From Baseline in Vital Signs: Respiratory Rate
Respiratory rate was collected in sitting position.
Measured: After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)
Change From Baseline in Vital Signs: Radial Pulse
Radial pulse was collected in sitting position.
Measured: pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 202312 Sep 2023

First posted11 Jan 2024
Study start21 Aug 2023
Primary completion12 Sep 2023
Study completion12 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06201559
Sponsor's protocol ID: 221030
Status last verified: Dec 2024
First submitted: 30 Dec 2023
Last updated: 27 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06201559
Acronym / sponsor ID: 221030
Conditions: Intestinal Diseases
Keywords: Albendazole, Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 21 Aug 2023 (actual)
Primary completion: 12 Sep 2023 (actual)
Study completion: 12 Sep 2023 (actual)
First posted: 11 Jan 2024 (actual)
Results: Posted 27 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence TRTR	Experimental	Drug: Albendazole IP 400 mgParticipants will be administered with test (T) intervention [Albendazole Indian Pharmacopoeia (IP) 400 mg] in Period 1, reference (R) intervention (Albendazole Tablets 400 mg) in Period 2, T intervention in Period 3 and R intervention in Period 4.
Sequence RTRT	Experimental	Drug: Albendazole 400 mgParticipants will be administered with reference (R) intervention in Period 1, test (T) intervention in Period 2, R intervention in Period 3 and T intervention in Period 4.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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:

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Albendazole IP 400 mgAlbendazole IP 400 mg tablets will be administered under fed conditions	Drug	Sequence TRTR
Albendazole 400 mgAlbendazole 400 mg tablets will be administered under fed conditions	Drug	Sequence RTRT

Primary outcome

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.
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.

14 secondary outcomes

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
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
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
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
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
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
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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 22 days
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
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)
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)
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
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)
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

Results and safety

Results posted to the registry on 27 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test(T) Albendazole vs Reference(R) Albendazole First,Then (T) Albendazole vs (R) Albendazole (TRTR)	35	35
(R) Albendazole vs (T) Albendazole First,Then (R) Albendazole vs (T) Albendazole (RTRT)	35	35

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram/millilitre (ng/mL)

Measure	Albendazole IP 400 mg/400mg - Test 1 (T1) n = 64	Albendazole IP 400 mg/400 mg - Test 2 (T2) n = 61	Albendazole 400 mg/IP 400 mg - Reference 1 (R1) n = 63	Albendazole 400 mg/IP 400 mg - Reference 2 (R2) n = 62
Value	43.846 (114.1)	41.685 (110.9)	39.737 (112.1)	46.115 (102.6)

Albendazole IP 400 mg/400mg - Test 1 (T1) vs Albendazole IP 400 mg/400 mg - Test 2 (T2) vs Albendazole 400 mg/IP 400 mg - Reference 1 (R1) vs Albendazole 400 mg/IP 400 mg - Reference 2 (R2): Ratio of Geometric Least Square Means: 98.1 (90% CI 86.79 to 110.91)

Population analysed: PK population included all participants in Safety set who had at least 1 measurable PK assessment. As pre-specified in Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), and Reference Study Intervention-R1 and Reference Study Intervention-R2 similarly. Only those participants with data available at specified time points have been analyzed.

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

Measure	Albendazole IP 400 mg/400mg - Test 1 (T1) n = 63	Albendazole IP 400 mg/400mg - Test 2 (T2) n = 60	Albendazole 400 mg/ IP 400mg - Reference 1 (R1) n = 63	Albendazole 400 mg/ IP 400mg - Reference 2 (R2) n = 62
Value	179.419 (129.5)	164.052 (120.4)	161.034 (127.4)	182.792 (117.2)

Albendazole IP 400 mg/400mg - Test 1 (T1) vs Albendazole IP 400 mg/400mg - Test 2 (T2) vs Albendazole 400 mg/ IP 400mg - Reference 1 (R1) vs Albendazole 400 mg/ IP 400mg - Reference 2 (R2): Ratio of Geometric Least Square Means: 97.6 (90% CI 86.86 to 109.73)

Population analysed: PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected through the entire study duration of up to a maximum of 22 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Albendazole IP 400mg- Test (T)	1 of 67 (1.5%)	6 of 67 (9%)	0 of 67
Albendazole 400mg- Reference (R)	0 of 68 (0%)	6 of 68 (8.8%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Albendazole IP 400 mg and Albendazole 400 mg in people with Intestinal Diseases, run by GlaxoSmithKline at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06201559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.