Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate

An Open-label, Two-stage Study Evaluating Drug-drug Interaction Between Ciprofol Injectable Emulsion and Mefanamic Acid or Valproate in Healthy Volunteers

study the effect of mefanamic acid or valproate on ciprofol

Study Overview

• Status: Completed
• Conditions: Drug Drug Interaction
• Intervention / Treatment: Drug: Mefanamic Acid; Drug: Valproate

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hanzhou, China
    • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Normal results of physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), and 12-lead ECG, or considered by the investigator to be clinically insignificant abnormalities; no significant potential difficult airway (modified Mallampati score Class I-II);
• No previous history of primary diseases in major organs, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other hereditary disorders; no history of mental/neurological disorders; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
• Understand procedures and methods of this trial, willing to sign the informed consent form and comply strictly with the clinical trial protocol to complete this study.

Exclusion Criteria:

• Known allergies to excipients of ciprofol injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide), mefanamic acid, or valproate, or having contraindications to ciprofol/mefanamic acid/valproate; a history of drug allergies (including anesthetics), allergies, or prone to allergies;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MFA; mefanamic acid	Drug: Mefanamic Acid; mefanamic acid once every 6 hours on Day 4 and Day 5, Ciprofol on Day 1 and Day 5
Active Comparator: VPA; valproate	Drug: Valproate; valproate once daily on Day 4 to Day 8, Ciprofol on Day 1 and Day 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of mefanamic acid on the Cmax of ciprofol	Peak Plasma Concentration (Cmax)	0-24hour post ciprofol dosing
effect of mefanamic acid on the AUC of ciprofol	Area under the plasma concentration versus time curve (AUC)	0-24hour post ciprofol dosing
effect of valproate on the Cmax of ciprofol	Peak Plasma Concentration (Cmax)	0-24hour post ciprofol dosing
effect of valproate on the AUC of ciprofol	Area under the plasma concentration versus time curve (AUC)	0-24hour post ciprofol dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety when ciprofol is co-administered with mefanamic acid or valproate	Adverse event	0-24hour post ciprofol dosing
effect of mefanamic acid or valproate on the MOAA/S of ciprofol	MOAA/S	0-24hour post ciprofol dosing
effect of mefanamic acid or valproate on the BIS of ciprofol	BIS	0-24hour post ciprofol dosing

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 19, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; GABA Agents; Anticonvulsants; Antimanic Agents; Valproic Acid
• Other Study ID Numbers: HSK3486-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No