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Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Vicks Cough Syrup for Chesty Coughs | Experimental | Vicks Cough immediate-release (IR) syrup 15 mL (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast |
|
| Treatment B: Robitussin Extra Strength Chest Congestion | Experimental | Robitussin Extra Strength Chest Congestion 5 ml (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast |
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| Treatment C: Organ-I- NR tablet | Experimental | Organ-I- NR 200 mg guaifenesin tablet every 4 hours x 3 doses with 240 mL of water after an overnight fast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicks Cough Syrup for Chesty Coughs | Drug | Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Guaifenesin | Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration. | 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 |
| Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose | Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose. | 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 |
| Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose | Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose). | 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 |
| Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose | 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 | 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours |
| Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin | Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration. | 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 |
| Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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. |
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Inclusion Criteria:
Males and/or females between the ages of 19 and 55 years, inclusive.
Females of childbearing potential must be using one of the following acceptable birth control methods:
Abstinence is not an acceptable form of contraception; however, abstinent female subjects may be admitted to the study if they agree, and have signed a statement to the effect, that upon becoming sexually active, will use a condom with spermicide from screening through 30 days beyond completion of the study.
Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 of Period 1) or postmenopausal >2 years prior to Day 1 of Period 1. A follicle stimulating hormone (FSH) concentration >40 miU/mL must be obtained and recorded for any postmenopausal females.
Good general health as determined by the Principal Investigator's (PI) review of medical history, physical examination, vital sign measurements, electrocardiogram (ECG), and clinical laboratory measures.
Within 15% of ideal body weight (Table of 'Desirable Weights of Adults' Metropolitan Life Insurance Company, 1983).
Non-tobacco users, who have not used nicotine or nicotine-containing products for at least 365 days prior to Day 1 of Period 1.
Able to read, understand and sign the informed consent after the nature of the study has been explained.
Negative urine screen for drugs of abuse and alcohol at screening and each check in.
If female, negative finding on serum pregnancy test at screening and each check-in.
Exclusion Criteria:
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A total of 30 subjects entered the study, among them 27 subjects completed the study.
This was a single-centre study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Robitussin Extra Strength Chest Congestion | Drug | Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water |
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| Organ-I- NR tablet | Drug | Organ-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water |
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Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose. |
| 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 |
| Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin | T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel. | 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 |
| Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin | 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. | 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 |
| Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin | 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. | 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 |
| Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin | 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. | 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 |
| Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin | 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. | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours |
| Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin | 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. | 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours |
| Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin | Pharmacokinetic Parameter AUCR is the Ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf). | 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 |
| Accumulation Index (AI) of Guaifenesin | AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4). | 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 hours |
| Degree of Fluctuation (DF) of Guaifenesin | DF is the Degree of Fluctuation Index, calculated as (Cmax,ss - Cmin,ss) / Cav. | 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 |
| Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin | Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss - Cmin,ss) / Cmin,ss. | 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 |
| Up to day 2 (Period 3) |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| FG005 | 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 |
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| NOT COMPLETED |
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| Washout: 7 Days |
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| Period 2 |
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| Washout: 7 Days |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 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) |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race | Number | participants |
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| Weight | Mean | Standard Deviation | lb |
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| Elbow Breadth | Mean | Standard Deviation | in |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Guaifenesin | Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration. | Pharmacokinetic (PK) analyses were performed on the available data of the subjects that completed at least 1 period. | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose | Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose. | PK analyses | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose | Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose). | PK analyses | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose | 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 | PK analyses | Posted | Mean | Standard Deviation | ng/mL | 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours |
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| Primary | Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin | Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration. | PK analyses | Posted | Mean | Standard Deviation | hr | 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 |
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| Primary | Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose | Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose. | PK analyses | Posted | Mean | Standard Deviation | hr | 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 |
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| Primary | Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin | T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel. | PK analyses | Posted | Mean | Standard Deviation | hr | 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 |
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| Primary | Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin | 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. | PK analyses | Posted | Mean | Standard Deviation | 1/hr | 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 |
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| Primary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin | 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. | PK analyses | Posted | Mean | Standard Deviation | ng*hr/mL | 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 |
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| Primary | Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin | 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. | PK analyses | Posted | Mean | Standard Deviation | ng*hr/mL | 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 |
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| Primary | Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin | 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. | PK analyses | Posted | Mean | Standard Deviation | ng*hr/mL | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours |
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| Primary | Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin | 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. | PK analyses | Posted | Mean | Standard Deviation | ng*hr/mL | 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours |
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| Primary | Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin | Pharmacokinetic Parameter AUCR is the Ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf). | PK analyses | Posted | Mean | Standard Deviation | Ratio | 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 |
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| Primary | Accumulation Index (AI) of Guaifenesin | AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4). | PK analyses | Posted | Mean | Standard Deviation | Ratio | 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 hours |
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| Primary | Degree of Fluctuation (DF) of Guaifenesin | DF is the Degree of Fluctuation Index, calculated as (Cmax,ss - Cmin,ss) / Cav. | PK analyses | Posted | Mean | Standard Deviation | Percent fluctuation in concentration | 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 |
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| Primary | Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin | Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss - Cmin,ss) / Cmin,ss. | PK analyses | Posted | Mean | Standard Deviation | Percentage | 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 |
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| Secondary | Number of Participants With Adverse Events (AEs) | 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. | PK analyses | Posted | Number | participants | Up to day 2 (Period 3) |
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Up to day 2 (Period 3)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | 0 | 29 | 0 | 29 | 5 | 29 |
| EG001 | Treatment B | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | 0 | 28 | 0 | 28 | 1 | 28 |
| EG002 | Treatment C | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | 0 | 28 | 0 | 28 | 4 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
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| Clinical Research Director, Clinical Research | Reckitt Benckiser, Inc | clinicalrequests@rb.com |
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