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NCT03216278
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions
Phase 1 trial testing Dapagliflozin/metformin XR 5/500mg in Healthy Subjects in Fasted and Fed State in 284 participants. Completed in 22 May 2018.
22 May 2018
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 284 |
| Start date | 26 September 2017 |
| Primary completion | 22 May 2018 |
| Estimated completion | 22 May 2018 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Dapagliflozin/metformin XR 5/500mg — full drug profile →
- Dapagliflozin/metformin XR 5/500 mg — full drug profile →
- Dapagliflozin/metformin XR 5/500mg — full drug profile →
- Dapagliflozin/metformin XR 5/500mg — full drug profile →
- Dapagliflozin/metformin XR 10/1000mg — full drug profile →
- Dapagliflozin/metformin XR 10/1000mg — full drug profile →
- Dapagliflozin/metformin XR 10/1000mg — full drug profile →
- Dapagliflozin/metformin XR 10/1000mg — full drug profile →
Conditions studied
- Healthy Subjects in Fasted and Fed State — all drugs for Healthy Subjects in Fasted and Fed State →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 50, any sex, with Healthy Subjects in Fasted and Fed State. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
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 NCT03216278
- 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 NCT03216278 (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: 30 May 2018
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/NCT03216278.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing