---
title: Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers
nct_id: NCT02172261
overall_status: COMPLETED
phase: PHASE1
sponsor: Boehringer Ingelheim
study_type: INTERVENTIONAL
primary_condition: Healthy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02172261.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02172261"
ct_last_update_post_date: 2014-06-24
last_seen_at: "2026-05-12T06:17:11.514Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers

**Official Title:** Relative Bioavailability of Both BI 10773 and Glimepiride After Co-administration Compared to Multiple Oral Doses of BI 10773 (50 mg q.d.) Alone and a Single Dose of Glimepiride (1 mg) Alone in Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)

**NCT ID:** [NCT02172261](https://clinicaltrials.gov/study/NCT02172261)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 16
- **Lead Sponsor:** Boehringer Ingelheim
- **Conditions:** Healthy
- **Start Date:** 2009-04
- **CT.gov Last Update:** 2014-06-24

## Brief Summary

The objective was to investigate whether there was a drug-drug interaction between BI 10773 and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773 and glimepiride were determined when both drugs were given in combination compared to multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride given alone.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
* Age 18 to 50 years (incl.)
* BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP (Blood Pressure, PR (Pulse Rate) and ECG (Electrocardiogram)) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 30 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
* Glucose-6-phosphate dehydrogenase deficiency
```

## Arms

- **Sequence ABC** (EXPERIMENTAL) — 1. Treatment A: BI 10773 once daily from day 1 to 5
2. Treatment B: BI 10773 and glimepiride once on day 1
3. Treatment C: Glimepiride once on day 1
- **Sequence CAB** (EXPERIMENTAL) — 1. Treatment C: Glimepiride once on day 1
2. Treatment A: BI 10773 once daily from day 1 to 5
3. Treatment B: BI 10773 and glimepiride once on day 1

## Interventions

- **BI 10773** (DRUG)
- **Glimepiride** (DRUG)

## Primary Outcomes

- **AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773** _(time frame: up to 5 days)_
- **Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773** _(time frame: up to 5 days)_
- **AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of glimepiride** _(time frame: up to 4 days)_
- **Cmax (maximum measured concentration of the analyte in plasma) of glimepiride** _(time frame: up to 4 days)_

## Secondary Outcomes

- **AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) of glimepiride** _(time frame: up to 4 days)_
- **tmax (time from dosing to the maximum concentration of the analyte in plasma) of glimepiride** _(time frame: up to 4 days)_
- **λz (terminal rate constant in plasma) of glimepiride** _(time frame: up to 4 days)_
- **t½ (terminal half-life of the analyte in plasma) of glimepiride** _(time frame: up to 4 days)_
- **MRTpo (mean residence time of the analyte in the body after po administration) of glimepiride** _(time frame: up to 4 days)_
- **CL/F (apparent clearance of the analyte in the plasma after extravascular administration) of glimepiride** _(time frame: up to 4 days)_
- **Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of glimepiride** _(time frame: up to 4 days)_
- **tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773** _(time frame: up to 5 days)_
- **Aet1-t2 (amount of analyte eliminated in urine over the time interval from t1 to t2) of glimepiride** _(time frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1)_
- **fet1-t2 (fraction of analyte excreted unchanged in urine over the time interval from t1 to t2) of glimepiride** _(time frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1)_
- **CLR (renal clearance of the analyte) of glimepiride** _(time frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1)_
- **λz,ss (terminal rate constant of analyte in plasma at steady-state) of BI 10773** _(time frame: up to 5 days)_
- **t½,ss (terminal half-life of analyte in plasma at steady-state) of BI 10773** _(time frame: up to 5 days)_
- **MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) of BI 10773** _(time frame: up to 5 days)_
- **CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) of BI 10773** _(time frame: up to 5 days)_
- **Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) of BI 10773** _(time frame: up to 5 days)_
- **Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ) of BI 10773** _(time frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5)_
- **fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ) of BI 10773** _(time frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5)_
- **CLR,ss (renal clearance of the analyte at steady state) of BI 10773** _(time frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5)_
- **UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h)** _(time frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on days 1 and 5)_
- **Number of patients with abnormal findings in physical examination** _(time frame: Baseline and within 3-14 days after last glimepiride administration)_
- **Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)** _(time frame: Baseline, day 1 and within 3-14 days after last glimepiride administration)_
- **Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)** _(time frame: Baseline, day 1 and within 3-14 days after last glimepiride administration)_
- **Number of patients with abnormal findings in clinical laboratory tests** _(time frame: Baseline, day 1,4 and within 3-14 days after last glimepiride administration)_
- **Number of patients with adverse events** _(time frame: Up to 34 days)_
- **Assessment of tolerability by investigator on a 4-point scale** _(time frame: Within 3-14 days after last glimepiride administration)_
- **Number of patients with abnormal findings in glucose bedside tests** _(time frame: Pre-dose and 1, 2, 4, 7, 10, 14, 24 hours after glimepiride administration on day 1)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02172261.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02172261*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*