# Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers

> **NCT01560481** · PHASE1 · COMPLETED · sponsor: **Laboratorios Silanes S.A. de C.V.** · enrollment: 49 (actual)

## Conditions studied

- Healthy

## Interventions

- **DRUG:** Step A: metformin glycinate 620 mg single dose
- **DRUG:** Step A: metformin glycinate 1240 mg single dose
- **DRUG:** Step A: metformin glycinate 2480 mg single dose
- **DRUG:** Step A: metformin hydrochloride 1000 mg single dose
- **DRUG:** Step A: metformin glycinate 1240 mg,food intake
- **DRUG:** Step B: metformin glycinate 620 mg BID
- **DRUG:** Step B: metformin hydrochloride 500 mg BID

## Key facts

- **NCT ID:** NCT01560481
- **Lead sponsor:** Laboratorios Silanes S.A. de C.V.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-12
- **Primary completion:** 2012-03
- **Final completion:** 2013-03
- **Target enrollment:** 49 (ACTUAL)
- **Last updated:** 2018-01-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01560481

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01560481, "Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers". Retrieved via AI Analytics 2026-06-13 from https://api.ai-analytics.org/clinical/NCT01560481. Licensed CC0.

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