Levo Phencynonate Hydrochloride for the Prevention of Seasickness

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

Criteria

Inclusion Criteria:

• Subjects fulfilling the diagnostic criteria for motion sickness

• Have medical history for motion sickness

• During screening, the severity of sea sickness is assessed as moderate or above according to sea sickness severity scale.

• Adults for 18-55 years, male or female.

• Agree to participate the study and can sign the ICF independently.

Exclusion Criteria:

• Be allergic to the study drug or be allergic constitution

• ALT, AST≥ 1.5 times of ULN, Scr>ULN, or other clinical significant lab values.

• Abnormal ECG which is clinical significant judged by investigators, including:

QTc>normal range

• Have medical history for urination disorder

• Have headache, vertigo, dizziness or nsomnia caused by other diseases than motion sickness.

• Have active gastrointestinal diseases or overweight (BMI≥24kg/m2 )

• Have internal ear disease which may disturb the evaluation of motion sickness.

• Have glaucoma or posterior circulation ischemia

• Have anxiety, depression or other mental disease that investigator considering inadaptable to participate the study.

• Participated in other studies within the past 3 months.