Trial Outcomes & Findings for Glucophage Immediate Release (GIR) China Bioequivalence Study (NCT NCT03393208)
NCT ID: NCT03393208
Last Updated: 2019-07-15
Results Overview
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3
Results posted on
2019-07-15
Participant Flow
Participant milestones
| Measure |
First Test GIR (Fasting), Then Reference GIR (Fasting)
Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period.
|
First Reference GIR (Fasting), Then Test GIR (Fasting)
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period.
|
First Test GIR (Fed), Then Reference GIR (Fed)
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period.
|
First Reference GIR (Fed), Then Test GIR (Fed)
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period.
|
|---|---|---|---|---|
|
Treatment Period 1 (Day 1-Day 3)
STARTED
|
13
|
13
|
9
|
9
|
|
Treatment Period 1 (Day 1-Day 3)
COMPLETED
|
13
|
13
|
9
|
9
|
|
Treatment Period 1 (Day 1-Day 3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (Day 8- Day 10)
STARTED
|
13
|
13
|
9
|
9
|
|
Treatment Period 2 (Day 8- Day 10)
COMPLETED
|
13
|
13
|
9
|
9
|
|
Treatment Period 2 (Day 8- Day 10)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glucophage Immediate Release (GIR) China Bioequivalence Study
Baseline characteristics by cohort
| Measure |
First Test GIR (Fasting), Then Reference GIR (Fasting)
n=13 Participants
Participants received a single oral dose of 500 milligram (mg) of test Glucophage Immediate Release (GIR) tablet Sino-American Shanghai Squibb (SASS)/China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (Merck Santé in Semoy (MSS)/France) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period.
|
First Reference GIR (Fasting), Then Test GIR (Fasting)
n=13 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fasting condition. There was a wash-out period of 7 days between each treatment period.
|
First Test GIR (Fed), Then Reference GIR (Fed)
n=9 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg reference GIR (MSS/France) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period.
|
First Reference GIR (Fed), Then Test GIR (Fed)
n=9 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 followed by a single oral dose of 500 mg test GIR (SASS/China) on Day 8 in treatment period 2 under fed condition. There was a wash-out period of 7 days between each treatment period.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 7.39 • n=7 Participants
|
29.8 years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 7.03 • n=4 Participants
|
31.7 years
STANDARD_DEVIATION 7.65 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 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
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
44 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
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: The Pharmacokinetic (PK) Analysis Set included all participants who completed the study with adequate study drug compliance, without any relevant protocol violations with respect to factors likely to affect comparability of PK results, and with sufficient evaluable data to determine primary endpoints (AUC0-t and Cmax ) for both treatments.
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Metformin (GIR Tablet Active Ingredient)
|
6260 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 22.4
|
6280 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 16.3
|
4950 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 25.6
|
5020 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 23.3
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: The Pharmacokinetic analysis set.
Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Metformin (GIR Tablet Active Ingredient)
|
1110 ng/mL
Geometric Coefficient of Variation 30.1
|
1110 ng/mL
Geometric Coefficient of Variation 22.7
|
711 ng/mL
Geometric Coefficient of Variation 22.4
|
700 ng/mL
Geometric Coefficient of Variation 18.6
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: The Pharmacokinetic analysis set.
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration of Metformin (GIR Tablet Active Ingredient)
|
2.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
2.75 hours
Interval 1.5 to 5.0
|
2.75 hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: The Pharmacokinetic analysis set. Here "Number of particpants analyzed" signifies those participants who were evaluable for this outcome measure.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=25 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Apparent Terminal Half-Life (t1/2) of Metformin (GIR Tablet Active Ingredient)
|
4.38 hours
Geometric Coefficient of Variation 40.5
|
4.90 hours
Geometric Coefficient of Variation 47.4
|
4.23 hours
Geometric Coefficient of Variation 45.6
|
4.16 hours
Geometric Coefficient of Variation 67.3
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: The Pharmacokinetic analysis set. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=25 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Metformin (GIR Tablet Active Ingredient)
|
6520 ng*h/mL
Geometric Coefficient of Variation 20.2
|
6410 ng*h/mL
Geometric Coefficient of Variation 16.0
|
5070 ng*h/mL
Geometric Coefficient of Variation 25.0
|
5160 ng*h/mL
Geometric Coefficient of Variation 21.2
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: As AUCextra was \>20% of AUC0-inf, parameters derived from λz including AUCextra% were regarded as unreliable estimate of the extent of exposure and not calculated.
AUCextra% was defined as area under the curve from time tlast extrapolated to infinity as percentage of AUC 0-infinity. Here, tlast is the last sampling time at which the concentration is at or above the lower limit of quantification.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: As AUCextra was \>20% of AUC0-inf, parameters derived from λz were regarded as unreliable estimate of the extent of exposure and not calculated.
λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: The Pharmacokinetic analysis set. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=25 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Total Body Clearance (CL/f) of Metformin (GIR Tablet Active Ingredient)
|
76.7 liter per hour
Geometric Coefficient of Variation 20.2
|
78.0 liter per hour
Geometric Coefficient of Variation 16.0
|
98.6 liter per hour
Geometric Coefficient of Variation 25.0
|
96.8 liter per hour
Geometric Coefficient of Variation 21.2
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: The Pharmacokinetic analysis set. . Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Vz/f is defined as the distribution of a study drug between plasma and the rest of the body after oral dosing.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=25 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution at After Extravascular Administration (Vz/f) of Metformin (GIR Tablet Active Ingredient)
|
485 liter
Geometric Coefficient of Variation 46.6
|
551 liter
Geometric Coefficient of Variation 52.5
|
602 liter
Geometric Coefficient of Variation 34.3
|
581 liter
Geometric Coefficient of Variation 73.1
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3Population: As AUCextra was \>20% of AUC0-inf, Vss/f derived from λz was regarded as unreliable estimate of the extent of exposure and not calculated.
Vss/F was derived from concentration versus time data for all participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 15Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Any TEAE
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 15Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug. Here "number of particpants were analyzed who were evaluable for this outcome measure".
The laboratory measurements included hematology, blood chemistry and urinalysis. Vital sign assessment included blood pressure, pulse rate and body temperature. ECG parameters included heart rate, PR, QRS,QT, RR, QTcB and QTcF Here, we are reporting number of participants with clinically significant abnormalities in Vital signs, laboratory parameters, physical findings and ECG findings.
Outcome measures
| Measure |
Treatment A: Test GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 Participants
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters, Physical Examination Findings and 12-lead Electrocardiogram (ECG) Findings
Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters, Physical Examination Findings and 12-lead Electrocardiogram (ECG) Findings
Laboratory Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters, Physical Examination Findings and 12-lead Electrocardiogram (ECG) Findings
Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters, Physical Examination Findings and 12-lead Electrocardiogram (ECG) Findings
12-Lead Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A Test GIR (Fasting)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B Reference GIR (Fasting)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment A: Test GIR (Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B: Reference GIR (Fed)
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 |
Treatment A Test GIR (Fasting)
n=26 participants at risk
Participants received a single oral dose of 500 mg of test GIR tablet (SASS)/China) on Day 1 in treatment period 1 under fasting conditions.
|
Treatment B Reference GIR (Fasting)
n=26 participants at risk
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 1 in treatment period 1 fasting conditions.
|
Treatment A: Test GIR (Fed)
n=18 participants at risk
Participants received a single oral dose of 500 mg of test GIR tablet (SASS/ China) on Day 8 in treatment period 2 under fed conditions.
|
Treatment B: Reference GIR (Fed)
n=18 participants at risk
Participants received a single oral dose of 500 mg of reference GIR tablet (MSS/ France) on Day 8 in treatment period 2 under fed conditions.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anemia
|
3.8%
1/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to Day 15
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place