Last reviewed · How we verify
NCT01332890
A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
Phase 1 trial testing Sequence 1 in Healthy in 30 participants. Completed in 1 August 2011.
1 August 2011
Quick facts
| Lead sponsor | Yuhan Corporation |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 April 2011 |
| Primary completion | 1 August 2011 |
| Estimated completion | 1 August 2011 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Sequence 1 — full drug profile →
- Sequence 2 — full drug profile →
- Sequence 3
- Sequence 4 — full drug profile →
- Sequence 5 — full drug profile →
- Sequence 6 — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Yuhan Corporation — full company profile →
Who can join
Adults 20 to 50, male only, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacokinetics
Time frame: Blood sampling will be obtained on day 7 at each period.
Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.
Sponsor's own description
To evaluate drug-drug interaction
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 NCT01332890
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Healthy
Currently open trials in the same condition.
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Other Yuhan Corporation trials
Trials by the same sponsor.
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- NCT07265167 — Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects · Phase 1 · completed
- NCT07111468 — Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis · Phase 3 · completed
- NCT06920719 — Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects · Phase 1 · completed
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 NCT01332890 (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 Yuhan Corporation
- Last refreshed: 8 July 2014
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/NCT01332890.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing