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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole IP 400 mg | Drug | Albendazole IP 400 mg tablets will be administered under fed conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
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 **.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ahmedabad | 382481 | India |
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/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test(T) Albendazole vs Reference(R) Albendazole First,Then (T) Albendazole vs (R) Albendazole (TRTR) | Participants were orally administered with Albendazole [Indian Pharmacopoeia (IP)] 400 mg (T1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole 400 mg (R1) tablet in Period 2, then single dose Albendazole IP 400 mg (T2) tablet in Period 3 further followed by single dose Albendazole 400 mg (R2) tablet in Period 4 |
| FG001 | (R) Albendazole vs (T) Albendazole First,Then (R) Albendazole vs (T) Albendazole (RTRT) | Participants were orally administered with Albendazole 400 mg (R1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole IP 400 mg (T1) tablet in Period 2, then single dose Albendazole 400 mg (R2) tablet in Period 3 further followed by single dose Albendazole IP 400 mg (T2) tablet in Period 4 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
| |||||||||||||
| Period 4 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test(T) Albendazole vs Reference(R) Albendazole First,Then (T) Albendazole vs (R) Albendazole (TRTR) | Participants were orally administered with Albendazole [Indian Pharmacopoeia (IP)] 400 mg (T1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole 400 mg (R1) tablet in Period 2, then single dose Albendazole IP 400 mg (T2) tablet in Period 3 further followed by single dose Albendazole 400 mg (R2) tablet in Period 4 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/millilitre (ng/mL) | 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 |
|
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.
Safety Population included all randomized participants who received at least 1 dose of study medication. Each participant was counted once throughout the study for this analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albendazole IP 400mg- Test (T) | Participants received a single oral dose of 400 mg Albendazole Indian Pharmacopoeia (IP) tablet under fed conditions on Day 1 in either treatment Periods 1, 2, 3 and 4. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA v25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2023 | Sep 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2023 | Sep 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Albendazole 400 mg | Drug | Albendazole 400 mg tablets will be administered under fed conditions |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | (R) Albendazole vs (T) Albendazole First,Then (R) Albendazole vs (T) Albendazole (RTRT) | Participants were orally administered with Albendazole 400 mg (R1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole IP 400 mg (T1) tablet in Period 2, then single dose Albendazole 400 mg (R2) tablet in Period 3 further followed by single dose Albendazole IP 400 mg (T2) tablet in Period 4 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4. |
| OG001 | Albendazole IP 400 mg/400 mg - Test 2 (T2) | Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4. |
| OG002 | Albendazole 400 mg/IP 400 mg - Reference 1 (R1) | Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4. |
| OG003 | Albendazole 400 mg/IP 400 mg - Reference 2 (R2) | Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4. |
|
|
|
| Primary | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/ milliliter (ng*h/mL) | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour (h) | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour (h) | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | 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 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | 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 | 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. | Safety Population included all randomized participants who received at least 1 dose of study medication. Each participant was counted once throughout the study for this analysis. | Posted | Count of Participants | Participants | Up to 22 days |
|
|
|
| Secondary | Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic) | Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position. | Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period |
|
|
|
| Secondary | Absolute Values of Vital Signs: Respiratory Rate | Respiratory rate was collected in sitting position. | Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed. | Posted | Mean | Standard Deviation | breaths per minute (bpm) | At screening, after check-in and before check-out in each period (each period is of 1 day) |
|
|
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| Secondary | Absolute Values of Vital Signs: Radial Pulse | Radial pulse was collected in sitting position. | Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed. | Posted | Mean | Standard Deviation | beats per minute (bpm) | 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) |
|
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| Secondary | Change From Baseline in Vital Signs: Blood Pressure | Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position. | Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period |
|
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| Secondary | Change From Baseline in Vital Signs: Respiratory Rate | Respiratory rate was collected in sitting position. | Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed. | Posted | Mean | Standard Deviation | breaths per minute (bpm) | After Check-in (Baseline) and before Check-out for each period (each period is of 1 day) |
|
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| Secondary | Change From Baseline in Vital Signs: Radial Pulse | Radial pulse was collected in sitting position. | Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed. | Posted | Mean | Standard Deviation | beats per minute (bpm) | pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period |
|
|
|
| 0 |
| 67 |
| 1 |
| 67 |
| 6 |
| 67 |
| EG001 | Albendazole 400mg- Reference (R) | Participants received a single oral dose of 400 mg Albendazole tablet under fed conditions on Day 1 in either treatment Periods 1, 2, 3 and 4. | 0 | 68 | 0 | 68 | 6 | 68 |
| Pain | General disorders | MedDRA v25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v25.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA v25.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA v25.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v25.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA v25.0 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Albendazole sulfoxide |
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| Albendazole sulfoxide |
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| Albendazole sulfoxide |
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| Albendazole sulfoxide |
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| Albendazole sulfoxide |
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| DBP - Period 1, 2 Hrs Post Dose |
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| DBP - Period 1, 4 Hrs Post Dose |
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| DBP - Period 1, 6 Hrs Post Dose |
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| DBP - Period 1, 12 Hrs Post Dose |
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| DBP - Period 1, 24 Hrs Post Dose |
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| DBP - Period 2, Pre-Dose |
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| DBP - Period 2, 2 Hrs Post Dose |
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| DBP - Period 2, 4 Hrs Post Dose |
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| DBP - Period 2, 6 Hrs Post Dose |
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| DBP - Period 2,12 Hrs Post Dose |
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| DBP - Period 2, 24 Hrs Post Dose |
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| DBP - Period 3, Pre-Dose |
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| DBP - Period 3, 2 Hrs Post Dose |
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| DBP - Period 3, 4 Hrs Post Dose |
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| DBP - Period 3, 6 Hrs Post Dose |
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| DBP - Period 3,12 Hrs Post Dose |
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| DBP - Period 3, 24 Hrs Post Dose |
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| DBP - Period 4, Pre-Dose |
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| DBP - Period 4, 2 Hrs Post Dose |
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| DBP - Period 4, 4 Hrs Post Dose |
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| DBP - Period 4, 6 Hrs Post Dose |
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| DBP - Period 4, 12 Hrs Post Dose |
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| DBP - Period 4, 24 Hrs Post Dose |
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| SBP - Period 1, Pre-dose |
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| SBP - Period 1, 2 Hrs Post Dose |
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| SBP - Period 1, 4 Hrs Post Dose |
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| SBP - Period 1, 6 Hrs Post Dose |
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| SBP - Period 1, 12 Hrs Post Dose |
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| SBP - Period 1, 24 Hrs Post Dose |
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| SBP - Period 2, Pre-dose |
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| SBP - Period 2, 2 Hrs Post Dose |
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| SBP - Period 2, 4 Hrs Post Dose |
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| SBP - Period 2, 6 Hrs Post Dose |
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| SBP - Period 2, 12 Hrs Post Dose |
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| SBP - Period 2, 24 Hrs Post Dose |
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| SBP - Period 3, Pre-dose |
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| SBP - Period 3, 2 Hrs Post Dose |
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| SBP - Period 3, 4 Hrs Post Dose |
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| SBP - Period 3, 6 Hrs Post Dose |
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| SBP - Period 3, 12 Hrs Post Dose |
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| SBP - Period 3, 24 Hrs Post Dose |
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| SBP - Period 4, Pre-dose |
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| SBP - Period 4, 2 Hrs Post Dose |
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| SBP - Period 4, 4 Hrs Post Dose |
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| SBP - Period 4, 6 Hrs Post Dose |
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| SBP - Period 4, 12 Hrs Post Dose |
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| SBP - Period 4, 24 Hrs Post Dose |
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| Period 1, after Check-in |
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| Period 1, before Check-out |
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| Period 2, after Check-in |
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| Period 2, before Check-out |
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| Period 3, after Check-in |
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| Period 3, before Check-out |
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| Period 4, after Check-in |
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| Period 4, before Check-out |
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| Period 1, 2 Hrs Post Dose |
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| Period 1, 4 Hrs Post Dose |
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| Period 1, 6 Hrs Post Dose |
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| Period 1, 12 Hrs Post Dose |
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| Period 1, 24 Hrs Post Dose |
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| Period 2, Pre-dose |
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| Period 2, 2 Hrs Post Dose |
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| Period 2, 4 Hrs Post Dose |
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| Period 2, 6 Hrs Post Dose |
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| Period 2, 12 Hrs Post Dose |
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| Period 2, 24 Hrs Post Dose |
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| Period 3, Pre-dose |
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| Period 3, 2 Hrs Post Dose |
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| Period 3, 4 Hrs Post Dose |
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| Period 3, 6 Hrs Post Dose |
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| Period 3, 12 Hrs Post Dose |
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| Period 3, 24 Hrs Post Dose |
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| Period 4, Pre-dose |
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| Period 4, 2 Hrs Post Dose |
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| Period 4, 4 Hrs Post Dose |
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| Period 4, 6 Hrs Post Dose |
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| Period 4, 12 Hrs Post Dose |
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| Period 4, 24 Hrs Post Dose |
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| DBP - Period 1, 2 Hrs Post Dose |
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| DBP - Period 1, 4 Hrs Post Dose |
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| DBP - Period 1, 6 Hrs Post Dose |
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| DBP - Period 1, 12 Hrs Post Dose |
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| DBP - Period 1, 24 Hrs Post Dose |
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| DBP - Period 2, Pre-dose |
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| DBP - Period 2, 2 Hrs Post Dose |
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| DBP - Period 2, 4 Hrs Post Dose |
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| DBP - Period 2, 6 Hrs Post Dose |
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| DBP - Period 2, 12 Hrs Post Dose |
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| DBP - Period 2, 24 Hrs Post Dose |
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| DBP - Period 3, Pre-dose |
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| DBP - Period 3, 2 Hrs Post Dose |
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| DBP - Period 3, 4 Hrs Post Dose |
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| DBP - Period 3, 6 Hrs Post Dose |
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| DBP - Period 3, 12 Hrs Post Dose |
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| DBP - Period 3, 24 Hrs Post Dose |
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| DBP - Period 4, Pre-dose |
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| DBP - Period 4, 2 Hrs Post Dose |
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| DBP - Period 4, 4 Hrs Post Dose |
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| DBP - Period 4, 6 Hrs Post Dose |
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| DBP - Period 4, 12 Hrs Post Dose |
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| DBP - Period 4, 24 Hrs Post Dose |
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| SBP - Period 1, Pre-dose |
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| SBP - Period 1, 2 Hrs Post Dose |
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| SBP - Period 1, 4 Hrs Post Dose |
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| SBP - Period 1, 6 Hrs Post Dose |
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| SBP - Period 1, 12 Hrs Post Dose |
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| SBP - Period 1, 24 Hrs Post Dose |
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| SBP - Period 2, Pre-dose |
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| SBP - Period 2, 2 Hrs Post Dose |
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| SBP - Period 2, 4 Hrs Post Dose |
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| SBP - Period 2, 6 Hrs Post Dose |
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| SBP - Period 2, 12 Hrs Post Dose |
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| SBP - Period 2, 24 Hrs Post Dose |
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| SBP - Period 3, Pre-dose |
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| SBP - Period 3, 2 Hrs Post Dose |
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| SBP - Period 3, 4 Hrs Post Dose |
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| SBP - Period 3, 6 Hrs Post Dose |
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| SBP - Period 3, 12 Hrs Post Dose |
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| SBP - Period 3, 24 Hrs Post Dose |
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| SBP - Period 4, Pre-dose |
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| SBP - Period 4, 2 Hrs Post Dose |
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| SBP - Period 4, 4 Hrs Post Dose |
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| SBP - Period 4, 6 Hrs Post Dose |
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| SBP - Period 4, 12 Hrs Post Dose |
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| SBP - Period 4, 24 Hrs Post Dose |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 1, 2 Hrs Post Dose |
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| Period 1, 4 Hrs Post Dose |
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| Period 1, 6 Hrs Post Dose |
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| Period 1, 12 Hrs Post Dose |
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| Period 1, 24 Hrs Post Dose |
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| Period 2, Pre-dose |
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| Period 2, 2 Hrs Post Dose |
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| Period 2, 4 Hrs Post Dose |
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| Period 2, 6 Hrs Post Dose |
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| Period 2, 12 Hrs Post Dose |
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| Period 2, 24 Hrs Post Dose |
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| Period 3, Pre-dose |
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| Period 3, 2 Hrs Post Dose |
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| Period 3, 4 Hrs Post Dose |
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| Period 3, 6 Hrs Post Dose |
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| Period 3, 12 Hrs Post Dose3 |
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| Period 3, 24 Hrs Post Dose |
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| Period 4, Pre-dose |
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| Period 4, 2 Hrs Post Dose |
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| Period 4, 4 Hrs Post Dose |
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| Period 4, 6 Hrs Post Dose |
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| Period 4, 12 Hrs Post Dose |
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| Period 4, 24 Hrs Post Dose |
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