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NCT03210025
Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations
Phase 1 trial testing BF-Methyldopa 250mg Tablet in Healthy in 17 participants. Completed in 15 October 2017.
15 October 2017
Quick facts
| Lead sponsor | Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 17 |
| Start date | 20 September 2017 |
| Primary completion | 15 October 2017 |
| Estimated completion | 15 October 2017 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- BF-Methyldopa 250mg Tablet — full drug profile →
- Metopa Tab 250mg — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of the study is to compare the bioavailability of a generic product of methyldopa with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620). The plasma pharmacokinetic data of Methyldopa obtained from two formulations will be used to access the interchangeability of the products.
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 NCT03210025
- 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 NCT03210025 (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 Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
- Last refreshed: 18 January 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/NCT03210025.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing