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NCT06233240
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/1000 mg Relative to Originator
Phase 1 trial testing Sitagliptin and Metformin Hydrochloride Tablets Test product in Healthy Subjects in 34 participants. Status unknown.
29 May 2024
Quick facts
| Lead sponsor | Bio-innova Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 34 |
| Start date | 30 April 2024 |
| Primary completion | 29 May 2024 |
| Estimated completion | 12 June 2024 |
Drugs / interventions tested
- Sitagliptin and Metformin Hydrochloride Tablets Test product — full drug profile →
- Sitagliptin and Metformin Hydrochloride Tablets Reference product — full drug profile →
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
Bio-innova Co., Ltd — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fed condition and at least 7 days washout period between the doses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06233240
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Bio-innova Co., Ltd trials
Trials by the same sponsor.
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- NCT06233227 — Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule · Phase 1 · unknown
- NCT06248801 — Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets · Phase 1 · unknown
- NCT06233162 — Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets · Phase 1 · unknown
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 NCT06233240 (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 Bio-innova Co., Ltd
- Last refreshed: 31 January 2024
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/NCT06233240.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing