Trial Outcomes & Findings for To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers (NCT NCT03415243)
NCT ID: NCT03415243
Last Updated: 2019-06-24
Results Overview
Mean time to onset of gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 microcurie \[mcCi\] isotope-technetium-99m-diethylene-triamine-pentaacetate \[DTPA\]). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. Regions of interest (ROI) included the stomach, proximal small intestine, distal small intestine and colon.
COMPLETED
PHASE1
28 participants
Predose until 10 hours post dose on Day 1
2019-06-24
Participant Flow
Participants were recruited from one center in USA.
A total of 32 participants were screened, of whom 28 were randomized for treatment and 4 were screen failures.
Participant milestones
| Measure |
Treatment Group A
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 milligrams \[mg\] + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 milliliters (mL) of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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Treatment Group B
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Overall Study
STARTED
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14
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14
|
|
Overall Study
COMPLETED
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14
|
14
|
|
Overall Study
NOT COMPLETED
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0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Total
n=28 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
28.0 Years
STANDARD_DEVIATION 8.74 • n=14 Participants
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28.8 Years
STANDARD_DEVIATION 5.19 • n=14 Participants
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28.4 Years
STANDARD_DEVIATION 7.06 • n=28 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=14 Participants
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0 Participants
n=14 Participants
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0 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
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14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
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28 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Height
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183.1 Centimeters
STANDARD_DEVIATION 6.53 • n=14 Participants
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180.6 Centimeters
STANDARD_DEVIATION 7.00 • n=14 Participants
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181.9 Centimeters
STANDARD_DEVIATION 6.76 • n=28 Participants
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PRIMARY outcome
Timeframe: Predose until 10 hours post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Mean time to onset of gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 microcurie \[mcCi\] isotope-technetium-99m-diethylene-triamine-pentaacetate \[DTPA\]). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. Regions of interest (ROI) included the stomach, proximal small intestine, distal small intestine and colon.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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Mean Time to Onset of Gastric Emptying
|
1.107 minutes
Standard Deviation 1.2130
|
8.534 minutes
Standard Deviation 6.6062
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PRIMARY outcome
Timeframe: Predose until 10 hours post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Mean time to complete gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m-DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Mean Time to Complete Gastric Emptying
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121.2 minutes
Standard Deviation 47.76
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65.3 minutes
Standard Deviation 47.40
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PRIMARY outcome
Timeframe: Predose until 10 hours post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Mean time to gastric emptying by 25 percent (GE25%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Mean Time for Gastric Emptying by Measuring 25 Percent Values
|
12.614 minutes
Standard Deviation 6.8249
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12.171 minutes
Standard Deviation 9.1819
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PRIMARY outcome
Timeframe: Predose until 10 hours post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Mean time to gastric emptying by 50 percent (GE50%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Mean Time for Gastric Emptying by Measuring 50 Percent Values
|
22.643 minutes
Standard Deviation 11.4058
|
16.134 minutes
Standard Deviation 11.8721
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PRIMARY outcome
Timeframe: Predose until 10 hours post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Mean time to gastric emptying by 90 percent (GE90%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Mean Time for Gastric Emptying by Measuring 90 Percent Values
|
84.929 minutes
Standard Deviation 43.1606
|
36.214 minutes
Standard Deviation 33.7711
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PRIMARY outcome
Timeframe: 15 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration
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67.00 percentage of radiolabeled drug
Standard Deviation 13.260
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49.77 percentage of radiolabeled drug
Standard Deviation 42.193
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PRIMARY outcome
Timeframe: 30 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration
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33.24 percentage of radiolabeled drug
Standard Deviation 19.321
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20.87 percentage of radiolabeled drug
Standard Deviation 26.697
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PRIMARY outcome
Timeframe: 45 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration
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24.79 percentage of radiolabeled drug
Standard Deviation 16.334
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7.21 percentage of radiolabeled drug
Standard Deviation 11.387
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PRIMARY outcome
Timeframe: 60 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration
|
20.07 percentage of radiolabeled drug
Standard Deviation 13.885
|
4.26 percentage of radiolabeled drug
Standard Deviation 10.378
|
PRIMARY outcome
Timeframe: 75 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration
|
14.73 percentage of radiolabeled drug
Standard Deviation 13.350
|
3.28 percentage of radiolabeled drug
Standard Deviation 8.123
|
PRIMARY outcome
Timeframe: 90 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
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|---|---|---|
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Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration
|
8.84 percentage of radiolabeled drug
Standard Deviation 9.867
|
2.45 percentage of radiolabeled drug
Standard Deviation 6.164
|
PRIMARY outcome
Timeframe: 105 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
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Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration
|
6.06 percentage of radiolabeled drug
Standard Deviation 8.145
|
1.72 percentage of radiolabeled drug
Standard Deviation 5.279
|
PRIMARY outcome
Timeframe: 120 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Percentage of Radiolabeled Drug Remaining in the Stomach After 120 Minutes of Administration
|
4.34 percentage of radiolabeled drug
Standard Deviation 6.177
|
0.99 percentage of radiolabeled drug
Standard Deviation 3.546
|
PRIMARY outcome
Timeframe: 180 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Percentage of Radiolabeled Drug Remaining in the Stomach After 180 Minutes of Administration
|
0.64 percentage of radiolabeled drug
Standard Deviation 2.108
|
0.00 percentage of radiolabeled drug
Standard Deviation 0.000
|
PRIMARY outcome
Timeframe: 240 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Percentage of Radiolabeled Drug Remaining in the Stomach After 240 Minutes of Administration
|
0.00 percentage of radiolabeled drug
Standard Deviation 0.00
|
0.00 percentage of radiolabeled drug
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 15 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 15 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 15 Minutes
|
19.38 percentage dose*hour
Standard Error 0.511
|
16.96 percentage dose*hour
Standard Error 1.769
|
PRIMARY outcome
Timeframe: 30 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 30 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 30 Minutes
|
31.16 percentage dose*hour
Standard Error 1.598
|
25.11 percentage dose*hour
Standard Error 3.873
|
PRIMARY outcome
Timeframe: 45 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 45 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 45 Minutes
|
38.36 percentage dose*hour
Standard Error 2.727
|
28.19 percentage dose*hour
Standard Error 4.864
|
PRIMARY outcome
Timeframe: 60 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 60 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 60 Minutes
|
43.69 percentage dose*hour
Standard Error 3.620
|
29.60 percentage dose*hour
Standard Error 5.402
|
PRIMARY outcome
Timeframe: 75 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 75 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 75 Minutes
|
48.71 percentage dose*hour
Standard Error 4.659
|
30.61 percentage dose*hour
Standard Error 5.888
|
PRIMARY outcome
Timeframe: 90 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 90 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 90 Minutes
|
51.32 percentage dose*hour
Standard Error 5.242
|
31.29 percentage dose*hour
Standard Error 6.236
|
PRIMARY outcome
Timeframe: 105 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 105 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 105 Minutes
|
53.16 percentage dose*hour
Standard Error 5.745
|
31.81 percentage dose*hour
Standard Error 6.529
|
PRIMARY outcome
Timeframe: 120 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 120 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 120 Minutes
|
54.49 percentage dose*hour
Standard Error 6.138
|
32.15 percentage dose*hour
Standard Error 6.743
|
PRIMARY outcome
Timeframe: 180 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 180 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 180 Minutes
|
56.69 percentage dose*hour
Standard Error 6.992
|
32.61 percentage dose*hour
Standard Error 7.069
|
PRIMARY outcome
Timeframe: 240 minutes post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Area under the gastric emptying curve from time 0 to 240 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Area Under the Gastric Emptying Curve From Time 0 to 240 Minutes
|
56.80 percentage dose*hour
Standard Error 7.071
|
32.61 percentage dose*hour
Standard Error 7.069
|
PRIMARY outcome
Timeframe: Predose until 10 hours post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Total area under the gastric emptying curve was evaluated by scintigraphic imaging, performed after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Total Area Under the Gastric Emptying Curve
|
56.80 percentage dose*hour
Standard Error 7.071
|
32.61 percentage dose*hour
Standard Error 7.069
|
PRIMARY outcome
Timeframe: Predose until 10 hours post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Gastric emptying half-life was defined as the time required by the stomach to empty 50% of the ingested meal and was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Gastric Emptying Half-Life
|
25.00 minutes
Interval 6.8 to 52.0
|
5.00 minutes
Interval 1.0 to 35.0
|
PRIMARY outcome
Timeframe: Predose until 10 hours post dose on Day 1Population: Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.
Small intestinal transit time was calculated by determining the arrival time of the radiolabeled investigational drug formulation at the cecum or colon region from scintigraphic imaging and subtracting the gastric emptying value.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Small Intestine Transit Time
|
184.0 minutes
Interval 106.0 to 265.0
|
139.5 minutes
Interval 61.0 to 243.0
|
SECONDARY outcome
Timeframe: From baseline up to Day 1Population: Safety population was defined as all participants who received a radiolabeled Treatment A or B irrespective of whether the participant was included in the scintigraphy analysis.
Haematological, biochemistry, urinalysis and virological parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter.
Outcome measures
| Measure |
Treatment Group A
n=14 Participants
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 Participants
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Laboratory Test Values
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment Group A
Treatment Group B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group A
n=14 participants at risk
Participants received single oral dose; 1 sachet of Theraflu Daytime Severe Cold and Cough radiolabeled powder (that contained Acetaminophen 650 mg + Phenylephrine 10 mg + Dextromethorphan 20 mg) for oral solution reconstituted with 225 mL of hot water. Participants were instructed to consume the hot drink entirely within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
Treatment Group B
n=14 participants at risk
Participants received single oral dose; 2 radiolabeled caplets of Theraflu ExpressMax Daytime Severe Cold and Cough (each caplet contained Acetaminophen 325 mg + Phenylephrine 5 mg + Dextromethorphan 10 mg) with 225 mL of room temperature non-carbonated water. Participants were instructed to consume all the water (225 mL) within 30 seconds on Day 1 morning after an overnight fast and no food or drink was allowed until 4 hours post-dose.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6)
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. All AEs were summarized by system organ class and preferred term. All treatment emergent AEs and SAEs were collected and reported.
|
7.1%
1/14 • Number of events 1 • From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6)
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. All AEs were summarized by system organ class and preferred term. All treatment emergent AEs and SAEs were collected and reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6)
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. All AEs were summarized by system organ class and preferred term. All treatment emergent AEs and SAEs were collected and reported.
|
7.1%
1/14 • Number of events 1 • From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6)
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. All AEs were summarized by system organ class and preferred term. All treatment emergent AEs and SAEs were collected and reported.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6)
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. All AEs were summarized by system organ class and preferred term. All treatment emergent AEs and SAEs were collected and reported.
|
0.00%
0/14 • From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6)
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. All AEs were summarized by system organ class and preferred term. All treatment emergent AEs and SAEs were collected and reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6)
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. All AEs were summarized by system organ class and preferred term. All treatment emergent AEs and SAEs were collected and reported.
|
7.1%
1/14 • Number of events 1 • From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6)
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis. All AEs were summarized by system organ class and preferred term. All treatment emergent AEs and SAEs were collected and reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER