Adults 18 to 45, any sex, with Intestinal Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Plasma Concentration (Cmax) of AlbendazolePrimary· 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.
Group
Value
95% CI
Albendazole IP 400 mg/400mg - Test 1 (T1)
43.846
± 114.1
Albendazole IP 400 mg/400 mg - Test 2 (T2)
41.685
± 110.9
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
39.737
± 112.1
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
46.115
± 102.6
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for AlbendazolePrimary· 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.
Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Group
Value
95% CI
Albendazole IP 400 mg/ 400mg - Test 1 (T1)
638.051
± 63.3
Albendazole IP 400 mg/ 400mg - Test 2 (T2)
644.730
± 59.4
Albendazole 400 mg/ IP 400mg - Reference 1 (R1)
643.276
± 62.6
Albendazole 400 mg/ IP 400mg - Reference 2 (R2)
710.382
± 53.8
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole SulfoxideSecondary· 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.
Group
Value
95% CI
Albendazole IP 400 mg/ 400mg - Test 1 (T1)
6129.744
± 74.2
Albendazole IP 400 mg/ 400mg - Test 2 (T2)
6023.449
± 68.9
Albendazole 400 mg/ IP 400mg - Reference 1 (R1)
6046.054
± 73.2
Albendazole 400 mg/ IP 400mg - Reference 2 (R2)
6572.338
± 67.8
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole SulfoxideSecondary· 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.
Albendazole
Group
Value
95% CI
Albendazole IP 400 mg/ 400 mg - Test 1 (T1)
189.347
± 128.6
Albendazole IP 400 mg/ 400 mg - Test 2 (T2)
174.979
± 119.0
Albendazole 400 mg / IP 400mg- Reference 1 (R1)
169.433
± 127.1
Albendazole 400 mg/ IP 400mg - Reference 2 (R2)
192.388
± 116.1
Albendazole sulfoxide
Group
Value
95% CI
Albendazole IP 400 mg/ 400 mg - Test 1 (T1)
7372.856
± 80.1
Albendazole IP 400 mg/ 400 mg - Test 2 (T2)
7189.644
± 73.4
Albendazole 400 mg / IP 400mg- Reference 1 (R1)
7204.107
± 81.2
Albendazole 400 mg/ IP 400mg - Reference 2 (R2)
7816.474
± 74.5
Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole SulfoxideSecondary· 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.
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Albendazole
Group
Value
95% CI
Albendazole IP 400 mg/ 400 mg - Test 1 (T1)
0.133
± 57.6
Albendazole IP 400 mg/ 400mg - Test 2 (T2)
0.125
± 61.8
Albendazole 400 mg/ IP 400mg - Reference 1 (R1)
0.136
± 60.8
Albendazole 400 mg/ IP 400mg - Reference 2 (R2)
0.123
± 43.8
Albendazole sulfoxide
Group
Value
95% CI
Albendazole IP 400 mg/ 400 mg - Test 1 (T1)
0.082
± 29.3
Albendazole IP 400 mg/ 400mg - Test 2 (T2)
0.085
± 40.7
Albendazole 400 mg/ IP 400mg - Reference 1 (R1)
0.084
± 33.0
Albendazole 400 mg/ IP 400mg - Reference 2 (R2)
0.086
± 38.9
Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole SulfoxideSecondary· 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.
Albendazole
Group
Value
95% CI
Albendazole IP 400 mg / 400mg- Test 1 (T1)
3.304
± 111.2
Albendazole IP 400 mg/ 400mg - Test 2 (T2)
3.241
± 99.0
Albendazole 400 mg/ IP 400mg - Reference 1 (R1)
3.763
± 112.6
Albendazole 400 mg/ IP 400mg - Reference 2 (R2)
3.275
± 90.6
Albendazole sulfoxide
Group
Value
95% CI
Albendazole IP 400 mg / 400mg- Test 1 (T1)
14.513
± 47.9
Albendazole IP 400 mg/ 400mg - Test 2 (T2)
13.726
± 45.7
Albendazole 400 mg/ IP 400mg - Reference 1 (R1)
13.795
± 45.1
Albendazole 400 mg/ IP 400mg - Reference 2 (R2)
13.243
± 50.8
Number of Participants With Treatment Emergent Adverse Events (TEAEs)Secondary· 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.
Group
Value
95% CI
Albendazole IP 400mg- Test (T)
7
Albendazole 400mg- Reference (R)
6
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)Secondary· 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.
DBP - Period 1, Pre-dose
Group
Value
95% CI
TRTR
76.1
± 4.17
RTRT
77.1
± 4.32
DBP - Period 1, 2 Hrs Post Dose
Group
Value
95% CI
TRTR
74.8
± 3.47
RTRT
75.7
± 3.50
DBP - Period 1, 4 Hrs Post Dose
Group
Value
95% CI
TRTR
74.6
± 4.41
RTRT
75.7
± 4.29
DBP - Period 1, 6 Hrs Post Dose
Group
Value
95% CI
TRTR
73.4
± 5.20
RTRT
71.4
± 3.90
DBP - Period 1, 12 Hrs Post Dose
Group
Value
95% CI
TRTR
73.9
± 5.22
RTRT
73.9
± 4.70
DBP - Period 1, 24 Hrs Post Dose
Group
Value
95% CI
TRTR
76.2
± 3.71
RTRT
75.5
± 2.83
DBP - Period 2, Pre-Dose
Group
Value
95% CI
TRTR
72.9
± 3.26
RTRT
75.7
± 3.38
DBP - Period 2, 2 Hrs Post Dose
Group
Value
95% CI
TRTR
71.4
± 5.55
RTRT
71.9
± 4.66
Absolute Values of Vital Signs: Respiratory RateSecondary· 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.
At Screening
Group
Value
95% CI
TRTR
15.5
± 2.08
RTRT
15.8
± 2.21
Period 1, after Check-in
Group
Value
95% CI
TRTR
17.0
± 2.13
RTRT
16.4
± 1.82
Period 1, before Check-out
Group
Value
95% CI
TRTR
16.5
± 2.69
RTRT
16.5
± 2.33
Period 2, after Check-in
Group
Value
95% CI
TRTR
17.3
± 2.72
RTRT
16.8
± 2.34
Period 2, before Check-out
Group
Value
95% CI
TRTR
17.6
± 2.41
RTRT
16.8
± 2.64
Period 3, after Check-in
Group
Value
95% CI
TRTR
16.9
± 2.24
RTRT
17.6
± 2.50
Period 3, before Check-out
Group
Value
95% CI
TRTR
17.0
± 1.95
RTRT
16.3
± 2.06
Period 4, after Check-in
Group
Value
95% CI
TRTR
18.6
± 2.20
RTRT
18.3
± 2.67
Adverse events — posted to ClinicalTrials.gov
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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 27 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06201559.