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NCT05753371
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
NA trial testing Metformin Hydrochloride 500 MG in Drug Use in 24 participants. Completed in 31 March 2022.
24 March 2022
Quick facts
| Lead sponsor | PT. Pyridam Farma Tbk |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 23 February 2022 |
| Primary completion | 24 March 2022 |
| Estimated completion | 31 March 2022 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Metformin Hydrochloride 500 MG
Conditions studied
- Drug Use — all drugs for Drug Use →
Sponsor
PT. Pyridam Farma Tbk
Who can join
Adults 18 to 52, any sex, with Drug Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT. Pyridam Farma Tbk is bioequivalent to its reference product, Glucophage® 500 mg film-coated tablets manufactured by PT. Merck Tbk, Indonesia under licensed Merck Sante SAS, France.
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 NCT05753371
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT05981742 — Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activiti · Phase 2 · completed
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Currently open trials in the same condition.
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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 NCT05753371 (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 PT. Pyridam Farma Tbk
- Last refreshed: 3 March 2023
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/NCT05753371.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing