---
title: Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects
nct_id: NCT01242826
overall_status: COMPLETED
phase: PHASE1
sponsor: Novo Nordisk A/S
study_type: INTERVENTIONAL
primary_condition: Diabetes
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01242826.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01242826"
ct_last_update_post_date: 2015-05-29
last_seen_at: "2026-05-12T07:33:04.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects

**Official Title:** A Trial Investigating the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 (BIAsp 50) in Healthy Chinese Subjects

**NCT ID:** [NCT01242826](https://clinicaltrials.gov/study/NCT01242826)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Novo Nordisk A/S
- **Conditions:** Diabetes, Healthy
- **Start Date:** 2011-02
- **Completion Date:** 2011-03
- **CT.gov Last Update:** 2015-05-29

## Brief Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp 50). In addition, the safety and tolerability of BIAsp 50 will be observed

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician)
* Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive)

Exclusion Criteria:

* Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the Investigator (the Physician)
* A history of any illness that, in the opinion of the Investigator (the Physician), might confound the results of the trial or a pose risk in administering the trial product to the subject
* Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening (trial entry)
* Not able or willing to refrain from smoking during the inpatient period
```

## Arms

- **A** (EXPERIMENTAL)

## Interventions

- **biphasic insulin aspart 50** (DRUG) — A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection

## Primary Outcomes

- **Area under the serum insulin aspart concentration-time curve from 0 to 24hours** _(time frame: 24 hours profile after single dose of trial drug)_

## Secondary Outcomes

- **Area under the serum insulin aspart concentration-time curve between different time intervals** _(time frame: 24 hours profile after single dose of trial drug)_
- **Maximum observed serum insulin aspart concentration** _(time frame: 24 hours profile after single dose of trial drug)_
- **Number of adverse events.** _(time frame: After 3-10 days of treatment)_
- **Number of hypoglycaemic events** _(time frame: After 3-10 days of treatment)_

## Locations (1)

- Beijing, Beijing Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — 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)_
- `locations.|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01242826*  
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