Trial Outcomes & Findings for A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects (NCT NCT05737069)
NCT ID: NCT05737069
Last Updated: 2024-09-19
Results Overview
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Results posted on
2024-09-19
Participant Flow
This study was conducted at a single center in China.
A total of 235 participants were screened of which 34 participants were enrolled in fasted cohort and 50 participants were enrolled in fed cohort. Participants were randomized in 1:1 ratio within each cohort (fasted and fed) to receive either one of the 2 treatment sequence: Test (T) product followed by Reference (R) product (TR) or Reference product followed by Test product (RT) as per cross-over design.
Participant milestones
| Measure |
Fasted Cohort: Test Product-Reference Product (TR)
Participants received one sachet of ibuprofen arginine granules 400 milligrams (mg) (test product), orally, once on Day 1 of Period 1 under fasting conditions followed by one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 2 under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 milliliters (mL) of warm water. There was a wash-out period of at least two days between the administration of each product.
|
Fasted Cohort: Reference Product-Test Product (RT)
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 under fasting conditions followed by one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 2 under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water. There was a wash-out period of at least two days between administration of each product.
|
Fed Cohort: Test Product-Reference Product (TR)
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 under fed conditions followed by one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 2 under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water. There was a wash-out period of at least two days between the administration of each product.
|
Fed Cohort: Reference Product-Test Product (RT)
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 under fed conditions followed by one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 2 under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water. There was a wash-out period of at least two days between administration of each product.
|
|---|---|---|---|---|
|
Period 1 (2 Days)
STARTED
|
17
|
17
|
25
|
25
|
|
Period 1 (2 Days)
COMPLETED
|
17
|
17
|
25
|
25
|
|
Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period (2 Days)
STARTED
|
17
|
17
|
25
|
25
|
|
Washout Period (2 Days)
COMPLETED
|
17
|
17
|
25
|
25
|
|
Washout Period (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2 (2 Days)
STARTED
|
17
|
17
|
25
|
25
|
|
Period 2 (2 Days)
COMPLETED
|
17
|
17
|
25
|
25
|
|
Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Fasted Cohort: Test Product-Reference Product (TR)
n=17 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 under fasting conditions followed by one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 2 under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water. There was a wash-out period of at least two days between the administration of each product.
|
Fasted Cohort: Reference Product-Test Product (RT)
n=17 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 under fasting conditions followed by one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 2 under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water. There was a wash-out period of at least two days between administration of each product.
|
Fed Cohort: Test Product-Reference Product (TR)
n=25 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 under fed conditions followed by one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 2 under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water. There was a wash-out period of at least two days between the administration of each product.
|
Fed Cohort: Reference Product-Test Product (RT)
n=25 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 under fed conditions followed by one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 2 under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water. There was a wash-out period of at least two days between administration of each product.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
84 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Han
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set was defined as the evaluable PK parameter data set obtained from randomized participants who received at least one dose of investigational product.
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Last Observed Concentration at Time t (AUC[0-t]) for Ibuprofen in Fasted Conditions
|
122.2406 hour*micrograms per milliliter
Geometric Coefficient of Variation 20.2
|
122.1489 hour*micrograms per milliliter
Geometric Coefficient of Variation 21.3
|
PRIMARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set.
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC(0-inf) = AUC(0-t) +Ct/λz where Ct was the plasma concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of AUC(0-inf). PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Infinity (AUC [0-inf]) for Ibuprofen in Fasted Conditions
|
124.8000 hour*micrograms per milliliter
Geometric Coefficient of Variation 21.0
|
124.5173 hour*micrograms per milliliter
Geometric Coefficient of Variation 22.0
|
PRIMARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set.
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax) for Ibuprofen in Fasted Conditions
|
54.400 micrograms per milliliter
Geometric Coefficient of Variation 16.7
|
55.368 micrograms per milliliter
Geometric Coefficient of Variation 15.9
|
PRIMARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set.
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=50 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=50 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
AUC(0-t) for Ibuprofen in Fed Conditions
|
114.2490 hour*micrograms per milliliter
Geometric Coefficient of Variation 18.1
|
115.2125 hour*micrograms per milliliter
Geometric Coefficient of Variation 18.0
|
PRIMARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure.
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC(0-inf) = AUC(0-t) +Ct/λz where Ct was the plasma concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of AUC(0-inf). PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=44 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=45 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
AUC (0-inf) for Ibuprofen in Fed Conditions
|
125.0559 hour*micrograms per milliliter
Geometric Coefficient of Variation 18.9
|
128.9471 hour*micrograms per milliliter
Geometric Coefficient of Variation 22.8
|
PRIMARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set.
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=50 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=50 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Cmax for Ibuprofen in Fed Conditions
|
17.8260 micrograms per milliliter
Geometric Coefficient of Variation 26.8
|
17.8573 micrograms per milliliter
Geometric Coefficient of Variation 25.9
|
SECONDARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set.
Blood samples were collected at indicated timepoints for the analysis of Tmax. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ibuprofen in Fasted Conditions
|
0.330 hour
Interval 0.17 to 0.75
|
0.330 hour
Interval 0.17 to 0.5
|
SECONDARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dosePopulation: Pharmacokinetic parameter set.
t1/2 was defined as elimination half-life calculated as t1/2 = ln (2)/λz where λz was terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Elimination Half-life (t1/2) of Ibuprofen in Fasted Conditions
|
2.2023 hour
Interval 1.7452 to 3.0346
|
2.1300 hour
Interval 1.6851 to 2.7077
|
SECONDARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set.
λz was defined as terminal elimination rate constant estimated by log-linear regression of the terminal part of the plasma concentration versus time curve. Blood samples were collected at indicated timepoints for the analysis of λz. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Terminal Elimination Rate Constant (λz) of Ibuprofen in Fasted Conditions
|
0.3155 per hour
Geometric Coefficient of Variation 12.8
|
0.3212 per hour
Geometric Coefficient of Variation 11.9
|
SECONDARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set.
%AUCex was calculated as %AUCex = (1- AUC\[0-t\] /AUC\[0-inf\])\*100%. Blood samples were collected at indicated timepoints for the analysis of %AUCex. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=34 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Percentage of Extrapolated Area of AUC(0-inf) (%AUCex) of Ibuprofen in Fasted Conditions
|
1.8299 percentage of AUC
Geometric Coefficient of Variation 46.6
|
1.7393 percentage of AUC
Geometric Coefficient of Variation 43.8
|
SECONDARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set.
Blood samples were collected at indicated timepoints for the analysis of Tmax. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=50 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=50 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
Tmax of Ibuprofen in Fed Conditions
|
4.500 hour
Interval 0.17 to 10.0
|
4.500 hour
Interval 0.5 to 10.0
|
SECONDARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dosePopulation: Pharmacokinetic parameter set. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure.
t1/2 was defined as elimination half-life calculated as t1/2 = ln (2)/λz where λz was terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=44 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=45 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
t1/2 of Ibuprofen in Fed Conditions
|
2.4053 hour
Interval 1.7676 to 4.601
|
2.3995 hour
Interval 1.7355 to 10.7675
|
SECONDARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure.
λz was defined as terminal elimination rate constant estimated by log-linear regression of the terminal part of the plasma concentration versus time curve. Blood samples were collected at indicated timepoints for the analysis of λz. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=44 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=45 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
λz of Ibuprofen in Fed Conditions
|
0.2653 per hour
Geometric Coefficient of Variation 27.0
|
0.2515 per hour
Geometric Coefficient of Variation 39.3
|
SECONDARY outcome
Timeframe: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dosePopulation: Pharmacokinetic Parameter Set. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure.
%AUCex was calculated as %AUCex = (1- AUC\[0-t\] /AUC\[0-inf\])\*100%. Blood samples were collected at indicated timepoints for the analysis of %AUCex. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=44 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=45 Participants
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
|---|---|---|
|
%AUCex of Ibuprofen in Fed Conditions
|
7.9436 percentage of AUC
Geometric Coefficient of Variation 69.8
|
8.3506 percentage of AUC
Geometric Coefficient of Variation 75.4
|
Adverse Events
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fed Cohort: Ibuprofen Arginine Granules 400 mg (Test)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Fed Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=34 participants at risk
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=34 participants at risk
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water.
|
Fed Cohort: Ibuprofen Arginine Granules 400 mg (Test)
n=50 participants at risk
Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water.
|
Fed Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
n=50 participants at risk
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water.
|
|---|---|---|---|---|
|
Investigations
White blood cells urine positive
|
8.8%
3/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
4.0%
2/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
4.0%
2/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Blood pressure decreased
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
10.0%
5/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.0%
1/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Blood uric acid increased
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
4.0%
2/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Eosinophil percentage increased
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.0%
1/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Heart rate decreased
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Heart rate increased
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Low density lipoprotein increased
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Neutrophil count decreased
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.0%
1/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Respiratory rate increased
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
6.0%
3/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Urinary occult blood positive
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
4.0%
2/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.0%
1/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Blood glucose increased
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.0%
1/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.0%
1/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
2.9%
1/34 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
0.00%
0/50 • From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON 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