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NCT03415243 · ClinicalTrials.gov registry record · Phase 1
To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT03415243: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT03415243 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03415243, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.
Primary Outcome
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 int
Interventions
- DRUG Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg
- DRUG Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2018-03-29 |
| Phase | Phase 1 |
What the finished NCT03415243 record still lists
NCT03415243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg is the first listed.
NCT03415243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03415243 about?
NCT03415243 is a clinical study titled "To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers". This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.
What is the current status of trial NCT03415243?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2018-03-01. Estimated completion is 2018-03-29.
What interventions are being tested in trial NCT03415243?
The interventions under investigation include: Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg (DRUG), Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg (DRUG).
Who is sponsoring clinical trial NCT03415243?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03415243's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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