Who is sponsoring NCT03643575?

NCT03643575 is sponsored by Reckitt Benckiser Inc..

What drugs are being tested in NCT03643575?

Interventions in NCT03643575: Vicks Cough Syrup for Chesty Coughs, Robitussin Extra Strength Chest Congestion, Organ-I- NR tablet.

What condition does NCT03643575 study?

NCT03643575 studies Healthy Subjects.

Is NCT03643575 still recruiting?

NCT03643575 is currently completed. Last updated 27 March 2019.

Are results published for NCT03643575?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-27 · How we verify

NCT03643575

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers.

Completed Phase 1 Results posted Last updated 27 March 2019

What this trial tests

Phase 1 trial testing Vicks Cough Syrup for Chesty Coughs in Healthy Subjects in 30 participants. Completed in 16 July 2009.

Timeline

30 June 2009

Primary endpoint
16 July 2009

16 July 2009

Quick facts

Lead sponsor	Reckitt Benckiser Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	30
Start date	30 June 2009
Primary completion	16 July 2009
Estimated completion	16 July 2009

Drugs / interventions tested

Vicks Cough Syrup for Chesty Coughs — full drug profile →
Robitussin Extra Strength Chest Congestion — full drug profile →
Organ-I- NR tablet — full drug profile →

Conditions studied

Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Reckitt Benckiser Inc. — full company profile →

Who can join

Adults 19 to 55, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin Primary · 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

Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration.

Group	Value	95% CI
Treatment A	1730	± 723
Treatment B	1230	± 456
Treatment C	1110	± 433

Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose Primary · 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

Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose.

Group	Value	95% CI
Treatment A	876	± 548
Treatment B	765	± 309
Treatment C	796	± 317

Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose Primary · 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 the dosing interval following the third dose (that is, 4 hours following the third dose).

Group	Value	95% CI
Treatment A	60.3	± 33.4
Treatment B	55.1	± 28.0
Treatment C	73.6	± 59.9

Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose Primary · 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours

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

Group	Value	95% CI
Treatment A	357	± 168
Treatment B	313	± 128
Treatment C	300	± 128

Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin Primary · 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

Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration.

Group	Value	95% CI
Treatment A	2.66	± 2.32
Treatment B	2.94	± 2.00
Treatment C	3.91	± 2.29

Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose Primary · 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

Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose.

Group	Value	95% CI
Treatment A	8.70	± 0.333
Treatment B	8.67	± 0.244
Treatment C	9.02	± 0.374

Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin Primary · 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

T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel.

Group	Value	95% CI
Treatment A	0.961	± 0.0973
Treatment B	1.04	± 0.138
Treatment C	0.941	± 0.130

Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin Primary · 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

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.

Group	Value	95% CI
Treatment A	0.729	± 0.0780
Treatment B	0.677	± 0.0898
Treatment C	0.750	± 0.0987

Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin Primary · 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

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.

Group	Value	95% CI
Treatment A	5588.99	± 2329.08
Treatment B	4369.98	± 1708.25
Treatment C	4223.74	± 1798.98

Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin Primary · 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

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.

Group	Value	95% CI
Treatment A	5596.33	± 2330.20
Treatment B	4427.06	± 1721.91
Treatment C	4232.61	± 1801.69

Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin Primary · 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours

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.

Group	Value	95% CI
Treatment A	2013.16	± 785.006
Treatment B	1490.15	± 579.667
Treatment C	1414.18	± 617.126

Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin Primary · 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours

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.

Group	Value	95% CI
Treatment A	1427.70	± 672.821
Treatment B	1253.09	± 511.519
Treatment C	1198.55	± 511.210

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to day 2 (Period 3). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment A

Serious: 0/29 (0%)

Deaths: 0/29

Treatment B

Serious: 0/28 (0%)

Deaths: 0/28

Treatment C

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (11 terms — click to expand)

Reaction	System	Treatment A	Treatment B	Treatment C
Headache	Nervous system disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Feeling hot	General disorders	—	—	—
Vessel puncture site haematoma	General disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—	—
Vulvovaginal pruritus	Reproductive system and breast disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—

Data from ClinicalTrials.gov NCT03643575 adverse events section.

Sponsor's own description

Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Vicks Cough Syrup for Chesty Coughs

Trials testing the same drug.

NCT03644095 — Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Health · Phase 1 · completed

Other recruiting trials for Healthy Subjects

Currently open trials in the same condition.

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Other Reckitt Benckiser Inc. trials

Trials by the same sponsor.

NCT03642262 — Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h · Phase 1 · completed
NCT03644108 — Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers · Phase 1 · completed
NCT03644095 — Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Health · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03643575 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Reckitt Benckiser Inc.
Last refreshed: 27 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03643575.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing