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Phase I Study to Evaluate the Safety and Pharmacokinetics of Emulsified Isoflurane in Healthy Volunteers

A Phase ?, Single-center, Randomized, Single-blind, Open-label, Non-comparative Study to Evaluate the Safety and Pharmacokinetics of Emulsified Isoflurane after Intravenous Bolus Injection in Healthy Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-12002547
Enrollment
Unknown
Registered
2012-09-29
Start date
2010-12-03
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of anesthesia

Interventions

Low:In this group, the volunteers receive emulsified isoflurane at the dose of 22.63mg/kg
Midddle:In this group, the volunteers receive emulsified isoflurane at the dose of 38.26mg/kg
High dose:The volunteers receive emulsified isoflurane at the dose of 49.73 mg/kg

Sponsors

Yichang HumanWell Pharmaceutical Co.,Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 28 Years

Inclusion criteria

Inclusion criteria: 1) Age 18~45 years old (50:50 male:female) healthy volunteer of American Society of Anesthesiologists (ASA) Physical Classification System status of P1; 2) Body Mass Index (BMI) 19~24 kg/m2; 3) Health volunteers assessed by medical history and physical examination: systolic blood pressure between 90~140mmHg; heart rate between 50~100bpm; pulse oxygen saturation > 95% when inspiring air; normal result for routine lab test, including complete blood count, chemical test, urine test and stool test; norma result for chest X Ray and standard 12-lead ECG; 4) Female subjects of childbearing potential having negative urine pregnancy tests and having been using specified birth control methods prior to dosing; 5) No systematic disease history; 6) Non-smoker and no history of alcohol or drug abuse.

Exclusion criteria

Exclusion criteria: 1) Any history of allergy, especially to isoflurane or lipid emulsion; 2) Any suspected history of malignant hyperthermia in the volunteer or his/her relatives; 3) Hyperlipidemia; 4) Known or expected difficult airway or suspected difficult airway; 5) Recent use of any drug within 2 weeks; 6) Recent participation in other clinical trial (within 1 month); 7) Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Plasma isoflurane concentration;Safty;

Secondary

MeasureTime frame
exhaled isoflurane concentration;

Countries

China

Contacts

Public ContactJin Liu

Department of Anesthesiology, West China Hospital, Sichuan University

scujinliu@yahoo.com.cn+86 28 85422520

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026