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NCT01350921
A Sequential, Open Label Study to Compare the Pharmacokinetics, Safety and Tolerability of Ticagrelor and Venlafaxine Given Concomitantly in Healthy Subjects Aged 18 to 45 Years
Phase 1 trial testing Ticagrelor in Drug Drug Interaction in 22 participants. Completed in 1 March 2012.
1 March 2012
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 22 |
| Start date | 1 May 2011 |
| Primary completion | 1 March 2012 |
| Estimated completion | 1 March 2012 |
| Sites | 2 locations across United States, Sweden |
Drugs / interventions tested
- Ticagrelor (ticagrelor) — full drug profile →
- Venlaflaxin — full drug profile →
Conditions studied
- Drug Drug Interaction — all drugs for Drug Drug Interaction →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 45, any sex, with Drug Drug Interaction. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax)
Time frame: Multiple assessments during day 8 and 9.
Venlafaxine and O-desmethylvenlafaxine (ODV) on Day 8 (after multiple dose administration of venlafaxine for 4 days) and Day 9 (after concomitant administration of venlafaxine and ticagrelor):
Sponsor's own description
Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy 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 NCT01350921
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other AstraZeneca 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 NCT01350921 (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 AstraZeneca
- Last refreshed: 29 March 2012
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/NCT01350921.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing