Trial Outcomes & Findings for Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers. (NCT NCT03643575)
NCT ID: NCT03643575
Last Updated: 2019-03-27
Results Overview
Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours
Results posted on
2019-03-27
Participant Flow
This was a single-centre study.
A total of 30 subjects entered the study, among them 27 subjects completed the study.
Participant milestones
| Measure |
Treatment Sequence 1
Period 1: Treatment A
Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 2
Period 1: Treatment B
Robitussin Extra Strength 5ml syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment A
Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 3
Period 1: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment A
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 4
Period 1: Treatment A
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 5
Period 1: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment A
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 6
Period 1: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment A
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period 1
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout: 7 Days
STARTED
|
4
|
5
|
5
|
4
|
5
|
5
|
|
Washout: 7 Days
COMPLETED
|
4
|
4
|
5
|
4
|
5
|
5
|
|
Washout: 7 Days
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
4
|
5
|
5
|
4
|
5
|
5
|
|
Period 2
COMPLETED
|
4
|
5
|
5
|
4
|
5
|
5
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
4
|
5
|
4
|
5
|
5
|
|
Period 3
COMPLETED
|
4
|
4
|
5
|
4
|
5
|
5
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1
Period 1: Treatment A
Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 2
Period 1: Treatment B
Robitussin Extra Strength 5ml syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment A
Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 3
Period 1: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment A
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 4
Period 1: Treatment A
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 5
Period 1: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment A
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
Treatment Sequence 6
Period 1: Treatment C
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 2: Treatment B
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Period 3: Treatment A
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
|
|---|---|---|---|---|---|---|
|
Washout: 7 Days
Withdrew consent due to illness
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Washout: 7 Days
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Washout: 7 Days
Non compliance check in
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers.
Baseline characteristics by cohort
| Measure |
Overall Study
n=30 Participants
Treatment A:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Treatment B:
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Treatment C:
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
There was a 7 days washout period between each administration
Participants randomized to receive either Treatment A or Treatment B or Treatment C in 3 Periods (Period 1, 2, 3) of 6 sequence (ABC, BCA, CAB, ACB, BAC, CBA)
|
|---|---|
|
Age, Continuous
|
26.0 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race
Asian
|
1 participants
n=5 Participants
|
|
Race
Black
|
1 participants
n=5 Participants
|
|
Race
Caucasian
|
25 participants
n=5 Participants
|
|
Race
European/Middle Eastern
|
1 participants
n=5 Participants
|
|
Race
Hispanic
|
2 participants
n=5 Participants
|
|
Weight
|
157.60 lb
STANDARD_DEVIATION 22.359 • n=5 Participants
|
|
Height
|
69.65 in
STANDARD_DEVIATION 3.246 • n=5 Participants
|
|
Frame Size
Small
|
4 participants
n=5 Participants
|
|
Frame Size
Medium
|
23 participants
n=5 Participants
|
|
Frame Size
Large
|
3 participants
n=5 Participants
|
|
Elbow Breadth
|
2.661 in
STANDARD_DEVIATION 0.2140 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: Pharmacokinetic (PK) analyses were performed on the available data of the subjects that completed at least 1 period.
Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
|
1730 ng/mL
Standard Deviation 723
|
1230 ng/mL
Standard Deviation 456
|
1110 ng/mL
Standard Deviation 433
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose
|
876 ng/mL
Standard Deviation 548
|
765 ng/mL
Standard Deviation 309
|
796 ng/mL
Standard Deviation 317
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose).
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose
|
60.3 ng/mL
Standard Deviation 33.4
|
55.1 ng/mL
Standard Deviation 28.0
|
73.6 ng/mL
Standard Deviation 59.9
|
PRIMARY outcome
Timeframe: 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hoursPopulation: PK analyses
Average plasma concentration (Cav) following the third dose, calculated as AUC(8-12) divided by the dosing interval, 4. Cav is calculated as AUC(8-12) / dosing interval, 4
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose
|
357 ng/mL
Standard Deviation 168
|
313 ng/mL
Standard Deviation 128
|
300 ng/mL
Standard Deviation 128
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
|
2.66 hr
Standard Deviation 2.32
|
2.94 hr
Standard Deviation 2.00
|
3.91 hr
Standard Deviation 2.29
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose
|
8.70 hr
Standard Deviation 0.333
|
8.67 hr
Standard Deviation 0.244
|
9.02 hr
Standard Deviation 0.374
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=27 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin
|
0.961 hr
Standard Deviation 0.0973
|
1.04 hr
Standard Deviation 0.138
|
0.941 hr
Standard Deviation 0.130
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
Kel is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., 3 or more non-zero plasma concentrations) in the terminal log-linear phase.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=27 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin
|
0.729 1/hr
Standard Deviation 0.0780
|
0.677 1/hr
Standard Deviation 0.0898
|
0.750 1/hr
Standard Deviation 0.0987
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
AUC(0-t) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin
|
5588.99 ng*hr/mL
Standard Deviation 2329.08
|
4369.98 ng*hr/mL
Standard Deviation 1708.25
|
4223.74 ng*hr/mL
Standard Deviation 1798.98
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
AUC(0-inf) is the area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/Kel, where Ct was the last measurable concentration and Kel is the apparent first-order terminal elimination rate constant.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=27 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin
|
5596.33 ng*hr/mL
Standard Deviation 2330.20
|
4427.06 ng*hr/mL
Standard Deviation 1721.91
|
4232.61 ng*hr/mL
Standard Deviation 1801.69
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hoursPopulation: PK analyses
AUC(0-4) is the area under the plasma concentration versus time curve from time 0 to 4 hours post dose (relative to first dose), as calculated by the linear trapezoidal method.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin
|
2013.16 ng*hr/mL
Standard Deviation 785.006
|
1490.15 ng*hr/mL
Standard Deviation 579.667
|
1414.18 ng*hr/mL
Standard Deviation 617.126
|
PRIMARY outcome
Timeframe: 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hoursPopulation: PK analyses
AUC(8-12) is the area under the plasma concentration versus time curve from time 8 to 12 hours postdose (relative to first dose), as calculated by the linear trapezoidal method.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin
|
1427.70 ng*hr/mL
Standard Deviation 672.821
|
1253.09 ng*hr/mL
Standard Deviation 511.519
|
1198.55 ng*hr/mL
Standard Deviation 511.210
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
Pharmacokinetic Parameter AUCR is the Ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf).
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=27 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
|
0.9986 Ratio
Standard Deviation 0.000592
|
0.9982 Ratio
Standard Deviation 0.001138
|
0.9978 Ratio
Standard Deviation 0.001724
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4 hours and 8, 8.5, 8.75, 9, 9.5, 10, 11, 12 hoursPopulation: PK analyses
AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4).
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Accumulation Index (AI) of Guaifenesin
|
0.7056 Ratio
Standard Deviation 0.1299
|
0.8420 Ratio
Standard Deviation 0.1180
|
0.8592 Ratio
Standard Deviation 0.1304
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
DF is the Degree of Fluctuation Index, calculated as (Cmax,ss - Cmin,ss) / Cav.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Degree of Fluctuation (DF) of Guaifenesin
|
2.220 Percent fluctuation in concentration
Standard Deviation 0.5508
|
2.312 Percent fluctuation in concentration
Standard Deviation 0.5221
|
2.463 Percent fluctuation in concentration
Standard Deviation 0.6758
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hoursPopulation: PK analyses
Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss - Cmin,ss) / Cmin,ss.
Outcome measures
| Measure |
Treatment A
n=26 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin
|
16.19 Percentage
Standard Deviation 10.03
|
15.62 Percentage
Standard Deviation 8.908
|
0.750 Percentage
Standard Deviation 0.0987
|
SECONDARY outcome
Timeframe: Up to day 2 (Period 3)Population: PK analyses
Intensity was determined by the Investigator. For symptomatic Adverse Events (AEs) the following definitions were applied. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.
Outcome measures
| Measure |
Treatment A
n=29 Participants
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 Participants
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 Participants
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
TEAE by severity: Mild
|
5 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AEs)
TEAE by severity: Moderate
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs)
TEAE by severity: Severe
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Relationship to IMP - Unlikely
|
5 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs)
Relationship to IMP - Possible
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs)
Relationship to IMP - Probable
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=29 participants at risk
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment B
n=28 participants at risk
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
Treatment C
n=28 participants at risk
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
1/29 • Number of events 1 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Number of events 1 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
3.6%
1/28 • Number of events 1 • Up to day 2 (Period 3)
|
|
General disorders
Feeling hot
|
3.4%
1/29 • Number of events 1 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
|
General disorders
Vessel puncture site haematoma
|
3.4%
1/29 • Number of events 2 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/29 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
3.6%
1/28 • Number of events 1 • Up to day 2 (Period 3)
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • Number of events 2 • Up to day 2 (Period 3)
|
3.6%
1/28 • Number of events 1 • Up to day 2 (Period 3)
|
7.1%
2/28 • Number of events 3 • Up to day 2 (Period 3)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.4%
1/29 • Number of events 1 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.4%
1/29 • Number of events 1 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/29 • Up to day 2 (Period 3)
|
0.00%
0/28 • Up to day 2 (Period 3)
|
3.6%
1/28 • Number of events 1 • Up to day 2 (Period 3)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place