Trial Outcomes & Findings for Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions (NCT NCT06201559)
NCT ID: NCT06201559
Last Updated: 2025-01-27
Results Overview
Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
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
Results posted on
2025-01-27
Participant Flow
Participant milestones
| Measure |
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
|
(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
|
|---|---|---|
|
Period 1
STARTED
|
35
|
35
|
|
Period 1
COMPLETED
|
35
|
35
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
34
|
34
|
|
Period 2
COMPLETED
|
34
|
34
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
35
|
34
|
|
Period 3
COMPLETED
|
35
|
34
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
|
Period 4
STARTED
|
33
|
32
|
|
Period 4
COMPLETED
|
33
|
32
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Test(T) Albendazole vs Reference(R) Albendazole First,Then (T) Albendazole vs (R) Albendazole (TRTR)
n=35 Participants
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
|
(R) Albendazole vs (T) Albendazole First,Then (R) Albendazole vs (T) Albendazole (RTRT)
n=35 Participants
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
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 Years
STANDARD_DEVIATION 5.25 • n=5 Participants
|
34.5 Years
STANDARD_DEVIATION 6.40 • n=7 Participants
|
33.2 Years
STANDARD_DEVIATION 5.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=64 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=61 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Albendazole
|
43.846 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 114.1
|
41.685 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 110.9
|
39.737 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 112.1
|
46.115 nanogram/millilitre (ng/mL)
Geometric Coefficient of Variation 102.6
|
PRIMARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=63 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=60 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole
|
179.419 Nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 129.5
|
164.052 Nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 120.4
|
161.034 Nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 127.4
|
182.792 Nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 117.2
|
SECONDARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=64 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=61 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide
|
638.051 ng/mL
Geometric Coefficient of Variation 63.3
|
644.730 ng/mL
Geometric Coefficient of Variation 59.4
|
643.276 ng/mL
Geometric Coefficient of Variation 62.6
|
710.382 ng/mL
Geometric Coefficient of Variation 53.8
|
SECONDARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=63 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=60 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide
|
6129.744 ng*h/mL
Geometric Coefficient of Variation 74.2
|
6023.449 ng*h/mL
Geometric Coefficient of Variation 68.9
|
6046.054 ng*h/mL
Geometric Coefficient of Variation 73.2
|
6572.338 ng*h/mL
Geometric Coefficient of Variation 67.8
|
SECONDARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=63 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=60 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide
Albendazole
|
189.347 ng*h/mL
Geometric Coefficient of Variation 128.6
|
174.979 ng*h/mL
Geometric Coefficient of Variation 119.0
|
169.433 ng*h/mL
Geometric Coefficient of Variation 127.1
|
192.388 ng*h/mL
Geometric Coefficient of Variation 116.1
|
|
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide
Albendazole sulfoxide
|
7372.856 ng*h/mL
Geometric Coefficient of Variation 80.1
|
7189.644 ng*h/mL
Geometric Coefficient of Variation 73.4
|
7204.107 ng*h/mL
Geometric Coefficient of Variation 81.2
|
7816.474 ng*h/mL
Geometric Coefficient of Variation 74.5
|
SECONDARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=64 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=61 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide
Albendazole
|
3.31 hour (h)
Geometric Coefficient of Variation 33.4
|
3.41 hour (h)
Geometric Coefficient of Variation 30.4
|
3.39 hour (h)
Geometric Coefficient of Variation 32.9
|
3.52 hour (h)
Geometric Coefficient of Variation 30.6
|
|
Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide
Albendazole sulfoxide
|
4.64 hour (h)
Geometric Coefficient of Variation 16.4
|
4.64 hour (h)
Geometric Coefficient of Variation 21.7
|
4.62 hour (h)
Geometric Coefficient of Variation 19.4
|
4.63 hour (h)
Geometric Coefficient of Variation 20.0
|
SECONDARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=63 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=60 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide
Albendazole
|
5.22 hour (h)
Geometric Coefficient of Variation 55.1
|
5.53 hour (h)
Geometric Coefficient of Variation 74.9
|
5.11 hour (h)
Geometric Coefficient of Variation 60.0
|
5.62 hour (h)
Geometric Coefficient of Variation 56.0
|
|
Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide
Albendazole sulfoxide
|
8.47 hour (h)
Geometric Coefficient of Variation 34.8
|
8.20 hour (h)
Geometric Coefficient of Variation 28.4
|
8.21 hour (h)
Geometric Coefficient of Variation 28.2
|
8.07 hour (h)
Geometric Coefficient of Variation 32.8
|
SECONDARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=63 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=60 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide
Albendazole
|
0.133 1/h
Geometric Coefficient of Variation 57.6
|
0.125 1/h
Geometric Coefficient of Variation 61.8
|
0.136 1/h
Geometric Coefficient of Variation 60.8
|
0.123 1/h
Geometric Coefficient of Variation 43.8
|
|
Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide
Albendazole sulfoxide
|
0.082 1/h
Geometric Coefficient of Variation 29.3
|
0.085 1/h
Geometric Coefficient of Variation 40.7
|
0.084 1/h
Geometric Coefficient of Variation 33.0
|
0.086 1/h
Geometric Coefficient of Variation 38.9
|
SECONDARY outcome
Timeframe: 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 hoursPopulation: 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.
Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=63 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=63 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.
|
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)
n=60 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.
|
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)
n=62 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.
|
|---|---|---|---|---|
|
Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide
Albendazole
|
3.304 Percentage
Geometric Coefficient of Variation 111.2
|
3.241 Percentage
Geometric Coefficient of Variation 99.0
|
3.763 Percentage
Geometric Coefficient of Variation 112.6
|
3.275 Percentage
Geometric Coefficient of Variation 90.6
|
|
Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide
Albendazole sulfoxide
|
14.513 Percentage
Geometric Coefficient of Variation 47.9
|
13.726 Percentage
Geometric Coefficient of Variation 45.7
|
13.795 Percentage
Geometric Coefficient of Variation 45.1
|
13.243 Percentage
Geometric Coefficient of Variation 50.8
|
SECONDARY outcome
Timeframe: Up to 22 daysPopulation: 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.
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.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=67 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=68 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
7 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each periodPopulation: 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.
Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=35 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=35 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 3, 2 Hrs Post Dose
|
73.6 millimeters of mercury (mmHg)
Standard Deviation 5.56
|
75.1 millimeters of mercury (mmHg)
Standard Deviation 4.43
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 1, Pre-dose
|
76.1 millimeters of mercury (mmHg)
Standard Deviation 4.17
|
77.1 millimeters of mercury (mmHg)
Standard Deviation 4.32
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 1, 2 Hrs Post Dose
|
74.8 millimeters of mercury (mmHg)
Standard Deviation 3.47
|
75.7 millimeters of mercury (mmHg)
Standard Deviation 3.50
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 1, 4 Hrs Post Dose
|
74.6 millimeters of mercury (mmHg)
Standard Deviation 4.41
|
75.7 millimeters of mercury (mmHg)
Standard Deviation 4.29
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 1, 6 Hrs Post Dose
|
73.4 millimeters of mercury (mmHg)
Standard Deviation 5.20
|
71.4 millimeters of mercury (mmHg)
Standard Deviation 3.90
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 1, 12 Hrs Post Dose
|
73.9 millimeters of mercury (mmHg)
Standard Deviation 5.22
|
73.9 millimeters of mercury (mmHg)
Standard Deviation 4.70
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 1, 24 Hrs Post Dose
|
76.2 millimeters of mercury (mmHg)
Standard Deviation 3.71
|
75.5 millimeters of mercury (mmHg)
Standard Deviation 2.83
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 2, Pre-Dose
|
72.9 millimeters of mercury (mmHg)
Standard Deviation 3.26
|
75.7 millimeters of mercury (mmHg)
Standard Deviation 3.38
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 2, 2 Hrs Post Dose
|
71.4 millimeters of mercury (mmHg)
Standard Deviation 5.55
|
71.9 millimeters of mercury (mmHg)
Standard Deviation 4.66
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 2, 4 Hrs Post Dose
|
70.3 millimeters of mercury (mmHg)
Standard Deviation 4.13
|
71.5 millimeters of mercury (mmHg)
Standard Deviation 4.89
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 2, 6 Hrs Post Dose
|
74.5 millimeters of mercury (mmHg)
Standard Deviation 2.29
|
74.2 millimeters of mercury (mmHg)
Standard Deviation 2.65
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 2,12 Hrs Post Dose
|
70.7 millimeters of mercury (mmHg)
Standard Deviation 5.62
|
73.2 millimeters of mercury (mmHg)
Standard Deviation 4.81
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 2, 24 Hrs Post Dose
|
76.2 millimeters of mercury (mmHg)
Standard Deviation 3.52
|
76.7 millimeters of mercury (mmHg)
Standard Deviation 4.02
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 3, Pre-Dose
|
78.9 millimeters of mercury (mmHg)
Standard Deviation 3.17
|
78.9 millimeters of mercury (mmHg)
Standard Deviation 3.48
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 3, 4 Hrs Post Dose
|
76.3 millimeters of mercury (mmHg)
Standard Deviation 5.47
|
73.3 millimeters of mercury (mmHg)
Standard Deviation 3.93
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 3, 6 Hrs Post Dose
|
75.1 millimeters of mercury (mmHg)
Standard Deviation 6.18
|
74.4 millimeters of mercury (mmHg)
Standard Deviation 4.78
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 3,12 Hrs Post Dose
|
75.0 millimeters of mercury (mmHg)
Standard Deviation 4.49
|
73.4 millimeters of mercury (mmHg)
Standard Deviation 4.05
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 3, 24 Hrs Post Dose
|
75.9 millimeters of mercury (mmHg)
Standard Deviation 2.80
|
75.7 millimeters of mercury (mmHg)
Standard Deviation 3.94
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 4, Pre-Dose
|
76.3 millimeters of mercury (mmHg)
Standard Deviation 3.47
|
76.0 millimeters of mercury (mmHg)
Standard Deviation 3.68
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 4, 2 Hrs Post Dose
|
72.5 millimeters of mercury (mmHg)
Standard Deviation 4.79
|
73.7 millimeters of mercury (mmHg)
Standard Deviation 4.51
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 4, 4 Hrs Post Dose
|
74.1 millimeters of mercury (mmHg)
Standard Deviation 2.61
|
73.8 millimeters of mercury (mmHg)
Standard Deviation 3.94
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 4, 6 Hrs Post Dose
|
73.2 millimeters of mercury (mmHg)
Standard Deviation 2.86
|
73.8 millimeters of mercury (mmHg)
Standard Deviation 3.34
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 4, 12 Hrs Post Dose
|
74.3 millimeters of mercury (mmHg)
Standard Deviation 3.47
|
74.7 millimeters of mercury (mmHg)
Standard Deviation 4.31
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
DBP - Period 4, 24 Hrs Post Dose
|
77.1 millimeters of mercury (mmHg)
Standard Deviation 2.46
|
75.6 millimeters of mercury (mmHg)
Standard Deviation 3.12
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 1, Pre-dose
|
116.1 millimeters of mercury (mmHg)
Standard Deviation 3.53
|
116.3 millimeters of mercury (mmHg)
Standard Deviation 3.22
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 1, 2 Hrs Post Dose
|
116.2 millimeters of mercury (mmHg)
Standard Deviation 3.46
|
116.9 millimeters of mercury (mmHg)
Standard Deviation 2.71
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 1, 4 Hrs Post Dose
|
116.3 millimeters of mercury (mmHg)
Standard Deviation 4.51
|
117.4 millimeters of mercury (mmHg)
Standard Deviation 3.99
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 1, 6 Hrs Post Dose
|
117.3 millimeters of mercury (mmHg)
Standard Deviation 4.60
|
119.5 millimeters of mercury (mmHg)
Standard Deviation 5.20
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 1, 12 Hrs Post Dose
|
116.5 millimeters of mercury (mmHg)
Standard Deviation 4.90
|
117.4 millimeters of mercury (mmHg)
Standard Deviation 4.02
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 1, 24 Hrs Post Dose
|
116.7 millimeters of mercury (mmHg)
Standard Deviation 3.29
|
117.0 millimeters of mercury (mmHg)
Standard Deviation 3.89
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 2, Pre-dose
|
113.9 millimeters of mercury (mmHg)
Standard Deviation 4.50
|
116.4 millimeters of mercury (mmHg)
Standard Deviation 3.12
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 2, 2 Hrs Post Dose
|
120.3 millimeters of mercury (mmHg)
Standard Deviation 4.64
|
119.8 millimeters of mercury (mmHg)
Standard Deviation 2.89
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 2, 4 Hrs Post Dose
|
119.4 millimeters of mercury (mmHg)
Standard Deviation 2.55
|
120.3 millimeters of mercury (mmHg)
Standard Deviation 4.07
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 2, 6 Hrs Post Dose
|
117.5 millimeters of mercury (mmHg)
Standard Deviation 3.90
|
116.8 millimeters of mercury (mmHg)
Standard Deviation 4.22
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 2, 12 Hrs Post Dose
|
118.6 millimeters of mercury (mmHg)
Standard Deviation 4.45
|
119.6 millimeters of mercury (mmHg)
Standard Deviation 4.21
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 2, 24 Hrs Post Dose
|
116.6 millimeters of mercury (mmHg)
Standard Deviation 3.70
|
117.0 millimeters of mercury (mmHg)
Standard Deviation 4.53
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 3, Pre-dose
|
118.7 millimeters of mercury (mmHg)
Standard Deviation 3.12
|
117.9 millimeters of mercury (mmHg)
Standard Deviation 3.73
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 3, 2 Hrs Post Dose
|
114.2 millimeters of mercury (mmHg)
Standard Deviation 4.14
|
115.7 millimeters of mercury (mmHg)
Standard Deviation 3.67
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 3, 4 Hrs Post Dose
|
115.9 millimeters of mercury (mmHg)
Standard Deviation 3.88
|
114.8 millimeters of mercury (mmHg)
Standard Deviation 3.51
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 3, 6 Hrs Post Dose
|
115.0 millimeters of mercury (mmHg)
Standard Deviation 4.40
|
115.2 millimeters of mercury (mmHg)
Standard Deviation 3.69
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 3, 12 Hrs Post Dose
|
115.4 millimeters of mercury (mmHg)
Standard Deviation 3.39
|
115.1 millimeters of mercury (mmHg)
Standard Deviation 3.33
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 3, 24 Hrs Post Dose
|
116.8 millimeters of mercury (mmHg)
Standard Deviation 3.89
|
116.0 millimeters of mercury (mmHg)
Standard Deviation 3.01
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 4, Pre-dose
|
117.0 millimeters of mercury (mmHg)
Standard Deviation 3.18
|
116.4 millimeters of mercury (mmHg)
Standard Deviation 2.99
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 4, 2 Hrs Post Dose
|
116.6 millimeters of mercury (mmHg)
Standard Deviation 3.20
|
116.3 millimeters of mercury (mmHg)
Standard Deviation 3.35
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 4, 4 Hrs Post Dose
|
116.6 millimeters of mercury (mmHg)
Standard Deviation 3.91
|
115.9 millimeters of mercury (mmHg)
Standard Deviation 4.23
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 4, 6 Hrs Post Dose
|
118.3 millimeters of mercury (mmHg)
Standard Deviation 3.43
|
119.1 millimeters of mercury (mmHg)
Standard Deviation 3.81
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 4, 12 Hrs Post Dose
|
116.3 millimeters of mercury (mmHg)
Standard Deviation 3.69
|
115.6 millimeters of mercury (mmHg)
Standard Deviation 3.94
|
—
|
—
|
|
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)
SBP - Period 4, 24 Hrs Post Dose
|
116.0 millimeters of mercury (mmHg)
Standard Deviation 3.13
|
115.2 millimeters of mercury (mmHg)
Standard Deviation 3.00
|
—
|
—
|
SECONDARY outcome
Timeframe: At screening, after check-in and before check-out in each period (each period is of 1 day)Population: 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.
Respiratory rate was collected in sitting position.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=35 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=35 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Absolute Values of Vital Signs: Respiratory Rate
At Screening
|
15.5 breaths per minute (bpm)
Standard Deviation 2.08
|
15.8 breaths per minute (bpm)
Standard Deviation 2.21
|
—
|
—
|
|
Absolute Values of Vital Signs: Respiratory Rate
Period 1, after Check-in
|
17.0 breaths per minute (bpm)
Standard Deviation 2.13
|
16.4 breaths per minute (bpm)
Standard Deviation 1.82
|
—
|
—
|
|
Absolute Values of Vital Signs: Respiratory Rate
Period 1, before Check-out
|
16.5 breaths per minute (bpm)
Standard Deviation 2.69
|
16.5 breaths per minute (bpm)
Standard Deviation 2.33
|
—
|
—
|
|
Absolute Values of Vital Signs: Respiratory Rate
Period 2, after Check-in
|
17.3 breaths per minute (bpm)
Standard Deviation 2.72
|
16.8 breaths per minute (bpm)
Standard Deviation 2.34
|
—
|
—
|
|
Absolute Values of Vital Signs: Respiratory Rate
Period 2, before Check-out
|
17.6 breaths per minute (bpm)
Standard Deviation 2.41
|
16.8 breaths per minute (bpm)
Standard Deviation 2.64
|
—
|
—
|
|
Absolute Values of Vital Signs: Respiratory Rate
Period 3, after Check-in
|
16.9 breaths per minute (bpm)
Standard Deviation 2.24
|
17.6 breaths per minute (bpm)
Standard Deviation 2.50
|
—
|
—
|
|
Absolute Values of Vital Signs: Respiratory Rate
Period 3, before Check-out
|
17.0 breaths per minute (bpm)
Standard Deviation 1.95
|
16.3 breaths per minute (bpm)
Standard Deviation 2.06
|
—
|
—
|
|
Absolute Values of Vital Signs: Respiratory Rate
Period 4, after Check-in
|
18.6 breaths per minute (bpm)
Standard Deviation 2.20
|
18.3 breaths per minute (bpm)
Standard Deviation 2.67
|
—
|
—
|
|
Absolute Values of Vital Signs: Respiratory Rate
Period 4, before Check-out
|
17.9 breaths per minute (bpm)
Standard Deviation 2.28
|
17.7 breaths per minute (bpm)
Standard Deviation 2.26
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Radial pulse was collected in sitting position.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=35 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=35 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Absolute Values of Vital Signs: Radial Pulse
Period 1, Pre-dose
|
72.9 beats per minute (bpm)
Standard Deviation 6.31
|
74.2 beats per minute (bpm)
Standard Deviation 6.62
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 1, 2 Hrs Post Dose
|
70.6 beats per minute (bpm)
Standard Deviation 3.49
|
70.4 beats per minute (bpm)
Standard Deviation 3.39
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 1, 4 Hrs Post Dose
|
73.4 beats per minute (bpm)
Standard Deviation 4.38
|
72.9 beats per minute (bpm)
Standard Deviation 4.53
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 1, 6 Hrs Post Dose
|
72.8 beats per minute (bpm)
Standard Deviation 3.73
|
71.1 beats per minute (bpm)
Standard Deviation 4.37
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 1, 12 Hrs Post Dose
|
72.1 beats per minute (bpm)
Standard Deviation 4.80
|
70.7 beats per minute (bpm)
Standard Deviation 3.73
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 1, 24 Hrs Post Dose
|
72.7 beats per minute (bpm)
Standard Deviation 3.60
|
71.4 beats per minute (bpm)
Standard Deviation 3.68
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 2, Pre-dose
|
72.4 beats per minute (bpm)
Standard Deviation 3.36
|
73.9 beats per minute (bpm)
Standard Deviation 5.48
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 2, 2 Hrs Post Dose
|
67.4 beats per minute (bpm)
Standard Deviation 4.48
|
68.0 beats per minute (bpm)
Standard Deviation 4.20
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 2, 4 Hrs Post Dose
|
67.9 beats per minute (bpm)
Standard Deviation 3.44
|
68.6 beats per minute (bpm)
Standard Deviation 4.20
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 2, 6 Hrs Post Dose
|
72.8 beats per minute (bpm)
Standard Deviation 5.05
|
74.2 beats per minute (bpm)
Standard Deviation 4.39
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 2, 12 Hrs Post Dose
|
70.2 beats per minute (bpm)
Standard Deviation 4.17
|
71.7 beats per minute (bpm)
Standard Deviation 5.41
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 2, 24 Hrs Post Dose
|
69.2 beats per minute (bpm)
Standard Deviation 3.92
|
71.0 beats per minute (bpm)
Standard Deviation 3.26
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 3, Pre-dose
|
75.6 beats per minute (bpm)
Standard Deviation 4.02
|
74.7 beats per minute (bpm)
Standard Deviation 6.32
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 3, 2 Hrs Post Dose
|
69.6 beats per minute (bpm)
Standard Deviation 5.27
|
71.9 beats per minute (bpm)
Standard Deviation 3.95
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 3, 4 Hrs Post Dose
|
70.8 beats per minute (bpm)
Standard Deviation 5.65
|
70.0 beats per minute (bpm)
Standard Deviation 3.66
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 3, 6 Hrs Post Dose
|
70.7 beats per minute (bpm)
Standard Deviation 5.22
|
71.9 beats per minute (bpm)
Standard Deviation 4.38
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 3, 12 Hrs Post Dose
|
73.0 beats per minute (bpm)
Standard Deviation 5.21
|
73.1 beats per minute (bpm)
Standard Deviation 3.52
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 3, 24 Hrs Post Dose
|
70.9 beats per minute (bpm)
Standard Deviation 5.56
|
70.6 beats per minute (bpm)
Standard Deviation 4.05
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 4, Pre-dose
|
75.0 beats per minute (bpm)
Standard Deviation 6.51
|
75.3 beats per minute (bpm)
Standard Deviation 7.10
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 4, 2 Hrs Post Dose
|
69.6 beats per minute (bpm)
Standard Deviation 5.04
|
68.8 beats per minute (bpm)
Standard Deviation 3.99
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 4, 4 Hrs Post Dose
|
72.2 beats per minute (bpm)
Standard Deviation 2.85
|
71.4 beats per minute (bpm)
Standard Deviation 4.17
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 4, 6 Hrs Post Dose
|
72.2 beats per minute (bpm)
Standard Deviation 2.98
|
72.0 beats per minute (bpm)
Standard Deviation 2.52
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 4, 12 Hrs Post Dose
|
70.6 beats per minute (bpm)
Standard Deviation 3.19
|
72.9 beats per minute (bpm)
Standard Deviation 3.10
|
—
|
—
|
|
Absolute Values of Vital Signs: Radial Pulse
Period 4, 24 Hrs Post Dose
|
69.9 beats per minute (bpm)
Standard Deviation 4.71
|
71.5 beats per minute (bpm)
Standard Deviation 5.20
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each periodPopulation: 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.
Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=35 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=35 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 4, Pre-dose
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 4, 2 Hrs Post Dose
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 4.18
|
-0.1 millimeters of mercury (mmHg)
Standard Deviation 3.82
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 4, 4 Hrs Post Dose
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 5.30
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 4.67
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 4, 6 Hrs Post Dose
|
1.3 millimeters of mercury (mmHg)
Standard Deviation 4.34
|
2.7 millimeters of mercury (mmHg)
Standard Deviation 3.66
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 4, 12 Hrs Post Dose
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 4.99
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 5.67
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 4, 24 Hrs Post Dose
|
-0.9 millimeters of mercury (mmHg)
Standard Deviation 4.27
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 3.66
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 1, Pre-dose
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 1, 2 Hrs Post Dose
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 5.66
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 5.71
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 1, 4 Hrs Post Dose
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 6.44
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 5.73
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 1, 6 Hrs Post Dose
|
-2.7 millimeters of mercury (mmHg)
Standard Deviation 6.86
|
-5.7 millimeters of mercury (mmHg)
Standard Deviation 6.14
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 1, 12 Hrs Post Dose
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 7.29
|
-3.2 millimeters of mercury (mmHg)
Standard Deviation 6.55
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 1, 24 Hrs Post Dose
|
0.1 millimeters of mercury (mmHg)
Standard Deviation 5.85
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 4.60
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 2, Pre-dose
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 2, 2 Hrs Post Dose
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 7.15
|
-3.8 millimeters of mercury (mmHg)
Standard Deviation 5.57
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 2, 4 Hrs Post Dose
|
-2.6 millimeters of mercury (mmHg)
Standard Deviation 5.35
|
-4.2 millimeters of mercury (mmHg)
Standard Deviation 6.23
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 2, 6 Hrs Post Dose
|
1.5 millimeters of mercury (mmHg)
Standard Deviation 3.53
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 4.06
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 2, 12 Hrs Post Dose
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 5.55
|
-2.5 millimeters of mercury (mmHg)
Standard Deviation 5.70
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 2, 24 Hrs Post Dose
|
3.3 millimeters of mercury (mmHg)
Standard Deviation 5.13
|
1.0 millimeters of mercury (mmHg)
Standard Deviation 5.93
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 3, Pre-dose
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 3, 2 Hrs Post Dose
|
-5.3 millimeters of mercury (mmHg)
Standard Deviation 6.77
|
-3.8 millimeters of mercury (mmHg)
Standard Deviation 5.09
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 3, 4 Hrs Post Dose
|
-2.6 millimeters of mercury (mmHg)
Standard Deviation 5.12
|
-5.7 millimeters of mercury (mmHg)
Standard Deviation 4.37
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 3, 6 Hrs Post Dose
|
-3.8 millimeters of mercury (mmHg)
Standard Deviation 6.82
|
-4.6 millimeters of mercury (mmHg)
Standard Deviation 6.18
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 3, 12 Hrs Post Dose
|
-3.9 millimeters of mercury (mmHg)
Standard Deviation 5.03
|
-5.6 millimeters of mercury (mmHg)
Standard Deviation 5.15
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 3, 24 Hrs Post Dose
|
-2.9 millimeters of mercury (mmHg)
Standard Deviation 3.83
|
-3.3 millimeters of mercury (mmHg)
Standard Deviation 4.89
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 4, Pre-dose
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 4, 2 Hrs Post Dose
|
-3.8 millimeters of mercury (mmHg)
Standard Deviation 5.69
|
-2.3 millimeters of mercury (mmHg)
Standard Deviation 4.60
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 4, 4 Hrs Post Dose
|
-2.3 millimeters of mercury (mmHg)
Standard Deviation 4.25
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 5.24
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 4, 6 Hrs Post Dose
|
-3.1 millimeters of mercury (mmHg)
Standard Deviation 4.35
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 4.34
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 4, 12 Hrs Post Dose
|
-2.0 millimeters of mercury (mmHg)
Standard Deviation 4.32
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 5.62
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
DBP - Period 4, 24 Hrs Post Dose
|
0.6 millimeters of mercury (mmHg)
Standard Deviation 4.52
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 4.38
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 1, Pre-dose
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 1, 2 Hrs Post Dose
|
0.1 millimeters of mercury (mmHg)
Standard Deviation 5.09
|
0.6 millimeters of mercury (mmHg)
Standard Deviation 4.10
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 1, 4 Hrs Post Dose
|
0.2 millimeters of mercury (mmHg)
Standard Deviation 5.50
|
1.1 millimeters of mercury (mmHg)
Standard Deviation 4.98
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 1, 6 Hrs Post Dose
|
1.1 millimeters of mercury (mmHg)
Standard Deviation 5.30
|
3.3 millimeters of mercury (mmHg)
Standard Deviation 6.21
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 1, 12 Hrs Post Dose
|
0.3 millimeters of mercury (mmHg)
Standard Deviation 5.69
|
1.1 millimeters of mercury (mmHg)
Standard Deviation 4.63
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 1, 24 Hrs Post Dose
|
0.6 millimeters of mercury (mmHg)
Standard Deviation 5.61
|
0.7 millimeters of mercury (mmHg)
Standard Deviation 5.72
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 2, Pre-dose
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 2, 2 Hrs Post Dose
|
6.4 millimeters of mercury (mmHg)
Standard Deviation 7.60
|
3.4 millimeters of mercury (mmHg)
Standard Deviation 3.39
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 2, 4 Hrs Post Dose
|
5.5 millimeters of mercury (mmHg)
Standard Deviation 6.09
|
3.9 millimeters of mercury (mmHg)
Standard Deviation 5.35
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 2, 6 Hrs Post Dose
|
3.6 millimeters of mercury (mmHg)
Standard Deviation 5.90
|
0.4 millimeters of mercury (mmHg)
Standard Deviation 5.12
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 2, 12 Hrs Post Dose
|
4.8 millimeters of mercury (mmHg)
Standard Deviation 6.08
|
3.2 millimeters of mercury (mmHg)
Standard Deviation 4.64
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 2, 24 Hrs Post Dose
|
2.8 millimeters of mercury (mmHg)
Standard Deviation 5.93
|
0.6 millimeters of mercury (mmHg)
Standard Deviation 6.10
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 3, Pre-dose
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 3, 2 Hrs Post Dose
|
-4.5 millimeters of mercury (mmHg)
Standard Deviation 4.95
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 4.58
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 3, 4 Hrs Post Dose
|
-2.8 millimeters of mercury (mmHg)
Standard Deviation 5.42
|
-3.1 millimeters of mercury (mmHg)
Standard Deviation 4.98
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 3, 6 Hrs Post Dose
|
-3.7 millimeters of mercury (mmHg)
Standard Deviation 5.18
|
-2.7 millimeters of mercury (mmHg)
Standard Deviation 4.84
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 3, 12 Hrs Post Dose
|
-3.3 millimeters of mercury (mmHg)
Standard Deviation 4.27
|
-2.8 millimeters of mercury (mmHg)
Standard Deviation 5.32
|
—
|
—
|
|
Change From Baseline in Vital Signs: Blood Pressure
SBP - Period 3, 24 Hrs Post Dose
|
-1.9 millimeters of mercury (mmHg)
Standard Deviation 4.17
|
-1.9 millimeters of mercury (mmHg)
Standard Deviation 4.13
|
—
|
—
|
SECONDARY outcome
Timeframe: After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)Population: 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.
Respiratory rate was collected in sitting position.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=33 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=34 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs: Respiratory Rate
Period 1
|
-0.6 breaths per minute (bpm)
Standard Deviation 3.72
|
0.2 breaths per minute (bpm)
Standard Deviation 2.26
|
—
|
—
|
|
Change From Baseline in Vital Signs: Respiratory Rate
Period 2
|
0.6 breaths per minute (bpm)
Standard Deviation 3.56
|
0.4 breaths per minute (bpm)
Standard Deviation 3.91
|
—
|
—
|
|
Change From Baseline in Vital Signs: Respiratory Rate
Period 3
|
0.2 breaths per minute (bpm)
Standard Deviation 2.53
|
-0.0 breaths per minute (bpm)
Standard Deviation 3.27
|
—
|
—
|
|
Change From Baseline in Vital Signs: Respiratory Rate
Period 4
|
0.9 breaths per minute (bpm)
Standard Deviation 3.41
|
1.3 breaths per minute (bpm)
Standard Deviation 3.07
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each periodPopulation: 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.
Radial pulse was collected in sitting position.
Outcome measures
| Measure |
Albendazole IP 400 mg/400mg - Test 1 (T1)
n=35 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.
|
Albendazole IP 400 mg/400 mg - Test 2 (T2)
n=35 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 1, Pre-dose
|
0.0 beats per minute (bpm)
Standard Deviation 0.00
|
0.0 beats per minute (bpm)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 1, 2 Hrs Post Dose
|
-2.2 beats per minute (bpm)
Standard Deviation 6.86
|
-3.8 beats per minute (bpm)
Standard Deviation 7.79
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 1, 4 Hrs Post Dose
|
0.6 beats per minute (bpm)
Standard Deviation 7.57
|
-1.3 beats per minute (bpm)
Standard Deviation 9.23
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 1, 6 Hrs Post Dose
|
-0.1 beats per minute (bpm)
Standard Deviation 7.87
|
-3.0 beats per minute (bpm)
Standard Deviation 7.71
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 1, 12 Hrs Post Dose
|
-0.7 beats per minute (bpm)
Standard Deviation 8.85
|
-3.4 beats per minute (bpm)
Standard Deviation 7.89
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 1, 24 Hrs Post Dose
|
-0.1 beats per minute (bpm)
Standard Deviation 7.64
|
-2.7 beats per minute (bpm)
Standard Deviation 7.96
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 2, Pre-dose
|
0.0 beats per minute (bpm)
Standard Deviation 0.00
|
0.0 beats per minute (bpm)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 2, 2 Hrs Post Dose
|
-5.0 beats per minute (bpm)
Standard Deviation 5.08
|
-5.9 beats per minute (bpm)
Standard Deviation 5.40
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 2, 4 Hrs Post Dose
|
-4.5 beats per minute (bpm)
Standard Deviation 5.05
|
-5.4 beats per minute (bpm)
Standard Deviation 6.23
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 2, 6 Hrs Post Dose
|
0.5 beats per minute (bpm)
Standard Deviation 5.95
|
0.3 beats per minute (bpm)
Standard Deviation 6.98
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 2, 12 Hrs Post Dose
|
-2.2 beats per minute (bpm)
Standard Deviation 5.71
|
-2.2 beats per minute (bpm)
Standard Deviation 8.41
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 2, 24 Hrs Post Dose
|
-3.2 beats per minute (bpm)
Standard Deviation 5.58
|
-2.9 beats per minute (bpm)
Standard Deviation 6.47
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 3, Pre-dose
|
0.0 beats per minute (bpm)
Standard Deviation 0.00
|
0.0 beats per minute (bpm)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 3, 2 Hrs Post Dose
|
-6.0 beats per minute (bpm)
Standard Deviation 6.41
|
-2.8 beats per minute (bpm)
Standard Deviation 6.70
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 3, 4 Hrs Post Dose
|
-4.8 beats per minute (bpm)
Standard Deviation 5.47
|
-4.7 beats per minute (bpm)
Standard Deviation 7.09
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 3, 6 Hrs Post Dose
|
-4.9 beats per minute (bpm)
Standard Deviation 6.32
|
-2.8 beats per minute (bpm)
Standard Deviation 7.72
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 3, 12 Hrs Post Dose3
|
-2.6 beats per minute (bpm)
Standard Deviation 7.82
|
-1.6 beats per minute (bpm)
Standard Deviation 7.07
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 3, 24 Hrs Post Dose
|
-4.7 beats per minute (bpm)
Standard Deviation 6.73
|
-4.1 beats per minute (bpm)
Standard Deviation 7.71
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 4, Pre-dose
|
0.0 beats per minute (bpm)
Standard Deviation 0.00
|
0.0 beats per minute (bpm)
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 4, 2 Hrs Post Dose
|
-5.4 beats per minute (bpm)
Standard Deviation 8.94
|
-6.5 beats per minute (bpm)
Standard Deviation 8.23
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 4, 4 Hrs Post Dose
|
-2.8 beats per minute (bpm)
Standard Deviation 8.16
|
-3.9 beats per minute (bpm)
Standard Deviation 8.44
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 4, 6 Hrs Post Dose
|
-2.8 beats per minute (bpm)
Standard Deviation 7.09
|
-3.3 beats per minute (bpm)
Standard Deviation 6.53
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 4, 12 Hrs Post Dose
|
-4.4 beats per minute (bpm)
Standard Deviation 7.27
|
-2.3 beats per minute (bpm)
Standard Deviation 7.30
|
—
|
—
|
|
Change From Baseline in Vital Signs: Radial Pulse
Period 4, 24 Hrs Post Dose
|
-5.1 beats per minute (bpm)
Standard Deviation 7.73
|
-3.8 beats per minute (bpm)
Standard Deviation 8.34
|
—
|
—
|
Adverse Events
Albendazole IP 400mg- Test (T)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Albendazole 400mg- Reference (R)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Albendazole IP 400mg- Test (T)
n=67 participants at risk
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.
|
Albendazole 400mg- Reference (R)
n=68 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/68 • 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.
|
Other adverse events
| Measure |
Albendazole IP 400mg- Test (T)
n=67 participants at risk
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.
|
Albendazole 400mg- Reference (R)
n=68 participants at risk
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.
|
|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/67 • 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.
|
1.5%
1/68 • Number of events 1 • 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.
|
|
General disorders
Pain
|
3.0%
2/67 • Number of events 2 • 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.
|
0.00%
0/68 • 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.
|
|
General disorders
Pyrexia
|
1.5%
1/67 • Number of events 1 • 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.
|
4.4%
3/68 • Number of events 3 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
2/67 • Number of events 2 • 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.
|
0.00%
0/68 • 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.
|
|
Injury, poisoning and procedural complications
Injury
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/68 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/68 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/68 • 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.
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/67 • Number of events 2 • 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.
|
2.9%
2/68 • Number of events 3 • 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.
|
|
Investigations
Platelet count decreased
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/68 • 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.
|
|
Investigations
Transaminases increased
|
0.00%
0/67 • 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.
|
1.5%
1/68 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/67 • 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.
|
1.5%
1/68 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER