# Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.

> **NCT06124495** · PHASE1 · COMPLETED · sponsor: **Galenicum Health** · enrollment: 58 (actual)

## Conditions studied

- Bioequivalence
- Diabetes Mellitus, Type 2

## Interventions

- **DRUG:** Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet

## Key facts

- **NCT ID:** NCT06124495
- **Lead sponsor:** Galenicum Health
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2023-01-13
- **Primary completion:** 2023-02-13
- **Final completion:** 2023-02-13
- **Target enrollment:** 58 (ACTUAL)
- **Last updated:** 2023-11-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06124495

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06124495, "Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT06124495. Licensed CC0.

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