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NCT02212938
Influence of a Standardised High Fat Breakfast on the Bioavailability of 10 mg BI 14332 CL Taken as Two Tablets of 5 mg q.d. in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Phase 1 trial testing BI 14332 CL in Healthy in 12 participants. Completed.
1 November 2006
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 September 2006 |
| Primary completion | 1 November 2006 |
Drugs / interventions tested
- BI 14332 CL — full drug profile →
- high fat breakfast
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
Adults 21 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.
-
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 192 hours after drug administration -
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 192 hours after drug administration
Sponsor's own description
To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast
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 NCT02212938
- 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 NCT02212938 (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 Boehringer Ingelheim
- Last refreshed: 7 August 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/NCT02212938.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing