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NCT01838967
A Randomized, Open-label, Single Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Cilnidipine 10 mg and Valsartan 160 mg After Oral Administration in Healthy Male Volunteers
Phase 1 trial testing C - V - C+V in Healthy in 54 participants. Completed in 1 October 2013.
1 June 2013
Quick facts
| Lead sponsor | IlDong Pharmaceutical Co Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 1 April 2013 |
| Primary completion | 1 June 2013 |
| Estimated completion | 1 October 2013 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- C - V - C+V — full drug profile →
- C - C+V - V — full drug profile →
- V - C - C+V — full drug profile →
- V - C+V - C — full drug profile →
- C+V - C - V
- C+V - V - C — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
IlDong Pharmaceutical Co Ltd — full company profile →
Who can join
Adults 20 to 40, 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.
-
Cmax of Cilnidipine 10 mg
Time frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose -
Cmax of Valsartan 160 mg
Time frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose -
AUClast of Cilnidipine 10 mg
Time frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose -
AUClast of Valsartan 160 mg
Time frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
Sponsor's own description
The investigators investigate the potential pharmacokinetic drug-drug interaction between Cilnidipine 10 mg and Valsartan 160 mg in healthy male volunteers who receive Cilnidipine 10 mg alone, Valsartan 160 mg , and both together in a 3 period repeatedly.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluation of the pharmacokinetic and pharmacodynamic drug interactions between cilnidipine and valsartan, in healthy volunteers.
Lee J, Lee H, Jang K, Lim KS, et al · · 2014 · cited 9× · PMID 25336921 · DOI 10.2147/dddt.s68574
Verify or expand the search:
- PubMed search for NCT01838967
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other IlDong Pharmaceutical Co Ltd trials
Trials by the same sponsor.
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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 NCT01838967 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IlDong Pharmaceutical Co Ltd
- Last refreshed: 11 October 2013
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/NCT01838967.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing