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NCT02028598
A Randomized, Open-labeled, 6-sequence, 3-period, 3-treatment Crossover Study to Evaluate the Effect of Co-administration of Clomipramine HCl (Condencia Tab.) 15mg and Sildenafil Citrate (Viagra Tab.) 100mg on the Safety and Pharmacokinetic/Pharmacodynamic Properties of Clomipramine and Sildenafil Compared to the Effects After Single Oral Administration in Healthy Male Volunteers
Phase 1 trial testing Treatment 1 in Healthy in 30 participants. Completed in 1 March 2014.
1 March 2014
Quick facts
| Lead sponsor | CTC Bio, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2014 |
| Primary completion | 1 March 2014 |
| Estimated completion | 1 March 2014 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Treatment 1 — full drug profile →
- Treatment 2 — full drug profile →
- Treatment 3 — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
CTC Bio, Inc. — full company profile →
Who can join
Adults 19 to 65, 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.
-
The systemic exposure measured as area under the curve (AUC)
Time frame: From Day 1(dosing) to Day 4(72hrs) -
The maximum concentration (Cmax)
Time frame: From Day 1(dosing) to Day 4(72hrs)
Sponsor's own description
The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the effects after single oral administration in Korean healthy male volunteers.
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 NCT02028598
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Healthy
Currently open trials in the same condition.
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Other CTC Bio, Inc. trials
Trials by the same sponsor.
- NCT04631874 — A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg" · 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 NCT02028598 (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 CTC Bio, Inc.
- Last refreshed: 12 September 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/NCT02028598.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing