Trial Outcomes & Findings for Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers (NCT NCT04626414)
NCT ID: NCT04626414
Last Updated: 2025-08-24
Results Overview
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition
Results posted on
2025-08-24
Participant Flow
32 subjects recruited. 8 subjects randomised to each sequence.
Participant milestones
| Measure |
Ferric Maltol Sequence A
Period 1 capsule-fed; Period 2 suspension-fed; Period 3 capsule-fasted; Period 4 suspension-fasted.
|
Ferric Maltol Sequence B
Period 1 suspension-fasted; Period 2 capsule-fed; Period 3 suspension-fed; Period 4 capsule-fasted.
|
Ferric Maltol Sequence C
Period 1 capsule-fasted; Period 2 suspension-fasted; Period 3 capsule-fed; Period 4 suspension-fed.
|
Ferric Maltol Sequence D
Period 1 suspension-fed; Period 2 capsule-fasted; Period 3 suspension-fasted; Period 4 capsule-fed.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Ferric Maltol Sequence A
n=8 Participants
Period 1 capsule-fed; Period 2 suspension fed; Period 3 capsule fasted; Period 4 suspension fasted.
|
Ferric Maltol Sequence B
n=8 Participants
Period 1 suspension fasted; Period 2 capsule-fed; Period 3 suspension fed; Period 4 capsule fasted.
|
Ferric Maltol Sequence C
n=8 Participants
Period 1 capsule fasted; Period 2 suspension fasted; Period 3 capsule fed; Period 4 suspension fed.
|
Ferric Maltol Sequence D
n=8 Participants
Period 1 suspension fed; Period 2 capsule fasted; Period 3 suspension fasted; Period 4 capsule fed.
|
Total
n=32 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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 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
|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
34.00 years
STANDARD_DEVIATION 11.05 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 6.44 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 8.82 • n=4 Participants
|
36.18 years
STANDARD_DEVIATION 8.90 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (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 (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
|
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)
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
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 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
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted conditionPopulation: Full Analysis Set Population
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension.
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted Condition
|
69.94 ratio
Interval 61.75 to 79.23
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed conditionPopulation: Full analysis set population
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Combined Periods of Fed Condition
|
99.11 ratio
Interval 87.5 to 112.27
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted conditionPopulation: FAS
Ratio of area under the curve (AUClast) of total serum iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fasted Condition
|
77.54 ratio
Interval 70.38 to 85.42
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed conditionPopulation: Full analysis set population
Ratio of area under the curve (AUClast) of total serum iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fed Condition
|
96.99 ratio
Interval 88.04 to 106.86
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK daysPopulation: Full Analysis Set Population
Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg ferric maltol capsule
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Capsule
|
147.27 ratio
Interval 130.01 to 166.81
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK daysPopulation: FAS
Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30 mg ferric maltol capsule
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Capsule
|
134.25 ratio
Interval 121.86 to 147.91
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK daysPopulation: FAS
Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Suspension
|
103.93 ratio
Interval 91.75 to 117.72
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK daysPopulation: FAS
Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Suspension
|
107.32 ratio
Interval 97.41 to 118.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS - If the Lambda z was not assigned, the values of associated PK parameters AUCinf was not calculated
Descriptive statistics of total serum iron concentration; Area Under the Curve (AUCinf) by formulation (suspension or capsule) and condition (fed and fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=10 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=19 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=10 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=13 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions
|
2922.46 h*ng/mL
Standard Deviation 1052.46
|
3694.05 h*ng/mL
Standard Deviation 1561.138
|
3330.98 h*ng/mL
Standard Deviation 2128.861
|
3445.41 h*ng/mL
Standard Deviation 2615.954
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of baseline corrected serum iron concentration; Maximum Concentration (Cmax), by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions
|
44.469 ng/mL
Standard Deviation 73.0572
|
89.938 ng/mL
Standard Deviation 50.9927
|
40.219 ng/mL
Standard Deviation 52.9715
|
33.250 ng/mL
Standard Deviation 23.0637
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of baseline corrected serum iron concentration; area under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions
|
56.150 h*ng/mL
Standard Deviation 964.9572
|
691.392 h*ng/mL
Standard Deviation 791.8671
|
2.503 h*ng/mL
Standard Deviation 889.0745
|
-9.436 h*ng/mL
Standard Deviation 693.2830
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS. If the Lambda z was not assigned, the values of associated PK parameters AUCinf was not calculated.
Descriptive statistics of baseline corrected serum iron concentration; Area Under the Curve from 0-infinity by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol glucuronide by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions
|
3579.063 ng/mL
Standard Deviation 1668.2120
|
5126.250 ng/mL
Standard Deviation 1996.0748
|
3597.500 ng/mL
Standard Deviation 1776.4390
|
7685.0 ng/mL
Standard Deviation 1920.3797
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of maltol glucuronide; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions
|
7335.93 h*ng/mL
Standard Deviation 2449.530
|
9083.82 h*ng/mL
Standard Deviation 2902.863
|
7802.52 h*ng/mL
Standard Deviation 2585.848
|
10410.89 h*ng/mL
Standard Deviation 2631.072
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Maltol; Cmax in Fasted and Fed Conditions
|
16.994 ng/mL
Standard Deviation 18.5420
|
20.531 ng/mL
Standard Deviation 16.0714
|
33.600 ng/mL
Standard Deviation 37.0501
|
34.656 ng/mL
Standard Deviation 25.2179
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS - If the Lambda z was not assigned, the values of associated PK parameters AUC last was not calculated.
Descriptive statistics of maltol; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=20 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=27 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=28 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=31 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Maltol; AUClast in Fasted and Fed Conditions
|
28.61 h*ng/mL
Standard Deviation 21.924
|
17.29 h*ng/mL
Standard Deviation 15.274
|
39.13 h*ng/mL
Standard Deviation 44.525
|
22.41 h*ng/mL
Standard Deviation 16.879
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of Maximum Concentration (Cmax) of transferrin saturation by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of TSAT; Cmax in Fasted and Fed Conditions
|
32.750 ng/mL
Standard Deviation 18.4793
|
43.031 ng/mL
Standard Deviation 12.9428
|
30.344 ng/mL
Standard Deviation 12.5970
|
30.188 ng/mL
Standard Deviation 9.3892
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of transferrin saturation; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of TSAT; AUClast in Fasted and Fed Conditions
|
509.90 h*ng/mL
Standard Deviation 201.915
|
644.62 h*ng/mL
Standard Deviation 176.724
|
484.64 h*ng/mL
Standard Deviation 153.990
|
513.62 h*ng/mL
Standard Deviation 193.642
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of Maximum Concentration (Cmax) of Total Iron Binding Capacity (TIBC) by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of TIBC; Cmax in Fasted and Fed Conditions
|
393.688 ng/mL
Standard Deviation 50.5208
|
394.781 ng/mL
Standard Deviation 50.9913
|
396.938 ng/mL
Standard Deviation 73.3577
|
394.656 ng/mL
Standard Deviation 46.5310
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of Total Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of TIBC; AUClast in Fasted and Fed Conditions
|
8719.09 h*ng/mL
Standard Deviation 1097.981
|
8880.52 h*ng/mL
Standard Deviation 1165.547
|
8718.02 h*ng/mL
Standard Deviation 1195.335
|
8878.43 h*ng/mL
Standard Deviation 1069.977
|
SECONDARY outcome
Timeframe: up to 2 weeks following last dosePopulation: Safety population
Descriptive statistics of Serious Adverse Events by formulation (suspension or capsule) and condition (fed and fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Summary of Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of Maximum Concentration (Cmax) of Unsaturated Iron Binding Capacity (UIBC) by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of UIBC; Cmax in Fasted and Fed Conditions
|
329.750 ng/mL
Standard Deviation 57.3298
|
323.250 ng/mL
Standard Deviation 59.0172
|
331.250 ng/mL
Standard Deviation 82.0668
|
322.375 ng/mL
Standard Deviation 55.7018
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1,1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of Unsaturated Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of UIBC; AUClast in Fasted and Fed Conditions
|
6836.84 h*ng/mL
Standard Deviation 1303.757
|
6432.85 h*ng/mL
Standard Deviation 1052.589
|
6939.53 h*ng/mL
Standard Deviation 1159.295
|
6978.71 h*ng/mL
Standard Deviation 1182.131
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of transferrin; Maximum concentration (Cmax) from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions
|
304.063 ng/mL
Standard Deviation 42.7332
|
302.594 ng/mL
Standard Deviation 44.5051
|
300.688 ng/mL
Standard Deviation 42.3316
|
303.031 ng/mL
Standard Deviation 40.1670
|
SECONDARY outcome
Timeframe: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dosePopulation: FAS
Descriptive statistics of transferrin; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions
|
6711.95 h*ng/mL
Standard Deviation 965.632
|
6774.38 h*ng/mL
Standard Deviation 948.865
|
6701.92 h*ng/mL
Standard Deviation 980.522
|
6837.00 h*ng/mL
Standard Deviation 936.103
|
SECONDARY outcome
Timeframe: From first dose of ferric maltol on Day 1 to study completionPopulation: Safety population
Treatment-Emergent Adverse Events from Day 1 to Day 22 (Study completion)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Treatment-Emergent Adverse Events
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From first dose of ferric maltol on Day 1 to study completionPopulation: Safety population
TEAE leading to premature discontinuation of study drug/PK assessments from Day 1 to study completion
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening to Day 8Population: Safety population
Descriptive statistics for changes in blood pressure from Screening to Day 8
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=8 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=8 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=8 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=8 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Vital Signs - Blood Pressure, Change From Day 1 to Day 8
Diastolic blood pressure
|
-0.5 mmHg
Standard Deviation 3.02
|
-0.3 mmHg
Standard Deviation 6.71
|
-3.6 mmHg
Standard Deviation 7.58
|
-2.4 mmHg
Standard Deviation 4.63
|
|
Vital Signs - Blood Pressure, Change From Day 1 to Day 8
Systolic blood pressure
|
-3.6 mmHg
Standard Deviation 6.25
|
-4.6 mmHg
Standard Deviation 10.90
|
-4.9 mmHg
Standard Deviation 14.59
|
-0.1 mmHg
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: Screening to Day 7Population: Safety population
Descriptive statistics for changes in heart rate from Screening to Day 7
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=8 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=8 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=8 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=8 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Vital Signs - Heart Rate, Change From Day 1 to Day 7
|
-0.8 beats/min
Standard Deviation 10.26
|
8.1 beats/min
Standard Deviation 8.69
|
11.1 beats/min
Standard Deviation 11.23
|
3.1 beats/min
Standard Deviation 6.13
|
SECONDARY outcome
Timeframe: Day 1 to Day 8 (24 hrs post-dose of last dosing)Population: Safety population
Number of participants having received concomitant medications by formulation (suspension or capsule)
Outcome measures
| Measure |
Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
30 mg ferric maltol capsule and 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 Participants
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 Participants
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
Summary of Received Concomitant Medication by Formulation
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
Adverse Events
30 mg Ferric Maltol Capsule in a Fed Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30 mg Ferric Maltol Capsule in a Fasted Condition
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
30 mg Ferric Maltol Capsule in a Fed Condition
n=32 participants at risk
Single dose of 30 mg ferric maltol capsule in a fed condition
|
30 mg Ferric Maltol Capsule in a Fasted Condition
n=32 participants at risk
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition
n=32 participants at risk
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition
n=32 participants at risk
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
|---|---|---|---|---|
|
General disorders
Vessel puncture site pain
|
0.00%
0/32 • 8 days
|
3.1%
1/32 • Number of events 1 • 8 days
|
3.1%
1/32 • Number of events 1 • 8 days
|
0.00%
0/32 • 8 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/32 • 8 days
|
0.00%
0/32 • 8 days
|
3.1%
1/32 • Number of events 1 • 8 days
|
0.00%
0/32 • 8 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • 8 days
|
0.00%
0/32 • 8 days
|
3.1%
1/32 • Number of events 1 • 8 days
|
0.00%
0/32 • 8 days
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • 8 days
|
3.1%
1/32 • Number of events 1 • 8 days
|
0.00%
0/32 • 8 days
|
6.2%
2/32 • Number of events 2 • 8 days
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/32 • 8 days
|
0.00%
0/32 • 8 days
|
0.00%
0/32 • 8 days
|
3.1%
1/32 • Number of events 1 • 8 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place