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NCT02157649
An Open-Label, Single-Dose, Crossover Comparative Bioavailability and Pharmacokinetic Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet With Immediate-Release Tablet
Phase 1 trial testing IR Tablet under Fasted conditions in Cough in 26 participants. Completed in 1 September 2014.
1 August 2014
Quick facts
| Lead sponsor | Nexgen Pharma, Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 1 June 2014 |
| Primary completion | 1 August 2014 |
| Estimated completion | 1 September 2014 |
| Sites | 1 location across Jordan |
Drugs / interventions tested
- IR Tablet under Fasted conditions — full drug profile →
- ER Tablet under Fed Conditions — full drug profile →
- ER Tablet under Fasted Conditions — 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.
-
Serum Levels of Codeine and Guaifenesin
Time frame: 20 samples over 24 hours
Blood samples drawn prior to dosing with tablets, then at 19 additional time points over the next 24 hours.
Sponsor's own description
The objectives of this study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet after a single administration; and (c) to assess the safety and tolerability of the Codeine/Guaifenesin extended-release and immediate release tablet formulations.
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 NCT02157649
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cough
Currently open trials in the same condition.
- NCT07171099 — Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children · Phase 3 · recruiting
- NCT06999577 — The Mechanism Versus PPI Trial · Phase 4 · recruiting
- NCT06979141 — Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia · Phase 3 · recruiting
- NCT06918756 — Development of a Cough Control Questionnaire (CCQ) · recruiting
- 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 NCT02157649 (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: 14 April 2015
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/NCT02157649.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing