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NCT02572375: COGUSS
An Open-Label, Randomized, Multiple-Dose, 2-Way Crossover Comparative Bioavailability Steady State Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet in Healthy Subjects
Phase 1 trial testing Codeine Phosphate/Guaifenesin ER Tablet in Cough in 38 participants. Completed in 1 January 2015.
1 November 2014
Quick facts
| Lead sponsor | Nexgen Pharma, Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 1 October 2014 |
| Primary completion | 1 November 2014 |
| Estimated completion | 1 January 2015 |
| Sites | 1 location across Jordan |
Drugs / interventions tested
- Codeine Phosphate/Guaifenesin ER Tablet — full drug profile →
- Codeine Phosphate/Guaifenesin IR Tablet — full drug profile →
Conditions studied
- Cough — all drugs for Cough →
Sponsor
Nexgen Pharma, Inc — full company profile →
Who can join
Adults 18 to 45, any sex, with Cough. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Peak Plasma Concentration (Cmax)
Time frame: One week
Determination peak plasma concentration of each active ingredient during 12 hours following six days of dosing -
Area under the plasma concentration versus time curve (AUC)
Time frame: One week
Determination of total area under the plasma concentration versus time curve (AUC) during the 12 hours following 6 days of dosing.
Sponsor's own description
The objectives of this pivotal study are: 1. to evaluate bioavailability of an extended-release and immediate release Codeine Phosphate/Guaifenesin tablet at steady state following multiple oral administration 2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended release formulation.
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:
- PubMed search for NCT02572375
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06979141 — Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia · Phase 3 · recruiting
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- NCT06878209 — Cough and Hemorrhoids · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02572375 (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 Nexgen Pharma, Inc
- Last refreshed: 27 March 2017
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/NCT02572375.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing