Trial Outcomes & Findings for Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers (NCT NCT03644095)
NCT ID: NCT03644095
Last Updated: 2019-06-19
Results Overview
Pharmacokinetic Parameter (Cmax) 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, 16 and 24 hours (post-dose) on Day 1 and 2
Results posted on
2019-06-19
Participant Flow
This was a single-centre study.
Total 30 subjects were enrolled in the study and all 30 subjects completed the study.
Participant milestones
| Measure |
Mucinex First, Then Vicks
Treatment Sequences 1: Treatment A in Period 1, then Treatment B in Period 2
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
There was a 7 days washout period between each administration.
|
Vicks First, Then Mucinex
Treatment Sequences 2: Treatment B in Period 1, then Treatment A in Period 2
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
There was a 7 days washout period between each administration.
|
|---|---|---|
|
Period 1
STARTED
|
15
|
15
|
|
Period 1
COMPLETED
|
15
|
15
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
15
|
15
|
|
Washout (7 Days)
COMPLETED
|
15
|
15
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
15
|
15
|
|
Period 2
COMPLETED
|
15
|
15
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Overall Study
n=30 Participants
Test (Treatment A): Subjects received a single PO (by mouth) dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO (by mouth) dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Period 1: Treatment A or Treatment B at Sequence AB
Period 2: Treatment B or Treatment A at Sequence BA
There was a 7 days washout period between each administration.
|
|---|---|
|
Age, Continuous
|
26.5 Years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
|
Weight
|
162.2 lb
STANDARD_DEVIATION 25.37 • n=5 Participants
|
|
Height
|
68.92 In
STANDARD_DEVIATION 4.062 • n=5 Participants
|
|
Body Mass Index
|
23.937 kg/m²
STANDARD_DEVIATION 2.6486 • 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, 16 and 24 hours (post-dose) on Day 1 and 2Population: The Pharmacokinetic (PK) parameters were calculated from individual plasma concentration-time data (using actual blood draw times).
Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.
Outcome measures
| Measure |
Reference (Treatment B)
n=30 Participants
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
Test (Treatment A)
n=30 Participants
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
|
1390 ng/mL
Standard Deviation 575
|
857 ng/mL
Standard Deviation 469
|
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, 16 and 24 hours (post-dose) on Day 1 and 2Population: PK Data Set
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 |
Reference (Treatment B)
n=30 Participants
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
Test (Treatment A)
n=30 Participants
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
|
4447.1 ng*hr/mL
Standard Deviation 1627.4
|
3404.7 ng*hr/mL
Standard Deviation 1661.1
|
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, 16 and 24 hours (post-dose) on Day 1 and 2Population: PK Data Set
Area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC 0-t + C last/kel, where C last is the last measurable concentration and kel is the apparent first-order terminal elimination rate constant.
Outcome measures
| Measure |
Reference (Treatment B)
n=30 Participants
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
Test (Treatment A)
n=30 Participants
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
|
4456.4 ng*hr/mL
Standard Deviation 1630.7
|
3442.0 ng*hr/mL
Standard Deviation 1674.8
|
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, 16 and 24 hours (post-dose) on Day 1 and 2Population: PK Data Set
Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.
Outcome measures
| Measure |
Reference (Treatment B)
n=30 Participants
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
Test (Treatment A)
n=30 Participants
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
|
3.05 hr
Standard Deviation 2.47
|
0.885 hr
Standard Deviation 0.537
|
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, 16 and 24 hours (post-dose) on Day 1 and 2Population: PK Data Set
Pharmacokinetic Parameter AUCR is the ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf)
Outcome measures
| Measure |
Reference (Treatment B)
n=30 Participants
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
Test (Treatment A)
n=30 Participants
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
|---|---|---|
|
Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
|
0.998 Ratio
Standard Deviation 0.00167
|
0.988 Ratio
Standard Deviation 0.0144
|
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, 16 and 24 hours (post-dose) on Day 1 and 2Population: PK Data Sets
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 |
Reference (Treatment B)
n=30 Participants
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
Test (Treatment A)
n=30 Participants
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
|---|---|---|
|
Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin
|
0.716 1/hr
Standard Deviation 0.110
|
0.373 1/hr
Standard Deviation 0.181
|
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, 16 and 24 hours (post-dose) on Day 1 and 2Population: PK Data Set
Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.
Outcome measures
| Measure |
Reference (Treatment B)
n=30 Participants
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
Test (Treatment A)
n=30 Participants
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
|---|---|---|
|
Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin
|
0.989 hr
Standard Deviation 0.147
|
2.26 hr
Standard Deviation 0.948
|
SECONDARY outcome
Timeframe: Upto Day 2Mild = AE does not limit usual activities;subject may experience slight discomfort; Moderate = AE results in some limitation of usual activities; subject may experience significant discomfort; Severe = AE results in an inability to carry out usual activities; Probable = Most likely that the AE was caused by study drug; Possible = Reasonable suspicion that the AE was caused by the study drug; Unlikely = Slight but remote chance that the AE was caused by study drug but the balance of judgment is that it was most likely not due to the study drug.
Outcome measures
| Measure |
Reference (Treatment B)
n=30 Participants
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
Test (Treatment A)
n=30 Participants
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
|---|---|---|
|
Number of Adverse Events (AE) of Participants
TEAE by severity: Mild
|
8 Events
|
7 Events
|
|
Number of Adverse Events (AE) of Participants
TEAE by severity: Moderate
|
0 Events
|
0 Events
|
|
Number of Adverse Events (AE) of Participants
Relationship to Drug: Probable
|
0 Events
|
0 Events
|
|
Number of Adverse Events (AE) of Participants
TEAE by severity: Severe
|
0 Events
|
0 Events
|
|
Number of Adverse Events (AE) of Participants
Relationship to Drug: Possible
|
3 Events
|
6 Events
|
|
Number of Adverse Events (AE) of Participants
Relationship to Drug: Unlikely
|
5 Events
|
1 Events
|
Adverse Events
Test (Treatment A)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Reference (Treatment B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test (Treatment A)
n=30 participants at risk
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
|
Reference (Treatment B)
n=30 participants at risk
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • Up to Day 17
|
0.00%
0/30 • Up to Day 17
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • Up to Day 17
|
0.00%
0/30 • Up to Day 17
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/30 • Up to Day 17
|
3.3%
1/30 • Number of events 1 • Up to Day 17
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/30 • Up to Day 17
|
3.3%
1/30 • Number of events 1 • Up to Day 17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • Number of events 1 • Up to Day 17
|
0.00%
0/30 • Up to Day 17
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Number of events 4 • Up to Day 17
|
6.7%
2/30 • Number of events 2 • Up to Day 17
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/30 • Up to Day 17
|
3.3%
1/30 • Number of events 2 • Up to Day 17
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/30 • Up to Day 17
|
3.3%
1/30 • Number of events 1 • Up to Day 17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/30 • Up to Day 17
|
3.3%
1/30 • Number of events 1 • Up to Day 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place