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NCT02374684
A Within-group Randomized, Double-Blind, Placebo-Controlled, Single/ Multiple Dose Study to Assess the Safety , Tolerability, Pharmacokinetics and Food Effect of Methosulide After Oral Administration In Healthy Adult Subjects.
Phase 1 trial testing Methosulide in Healthy in 92 participants. Completed in 1 February 2016.
1 February 2016
Quick facts
| Lead sponsor | Hubei Biological Medicine Industrial Technology Institute Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 1 February 2015 |
| Primary completion | 1 February 2016 |
| Estimated completion | 1 February 2016 |
| Sites | 1 location across China |
Drugs / interventions tested
- Methosulide — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
Who can join
Adults 18 to 45, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerability of single and repeated oral administration of Methosulide as measured by the frequency of drug-related clinical adverse events in healthy adults.
Time frame: Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days
Adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment
Sponsor's own description
The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics and food effect of Methosulide after oral administration in healthy adult subjects.
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 NCT02374684
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02374684 (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 Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
- Last refreshed: 17 February 2016
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/NCT02374684.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing