Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate

Study Overview
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Brief Summary
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study the effect of mefanamic acid or valproate on ciprofol

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

Conditions
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Drug Drug Interaction

Intervention / Treatment
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* Drug: Mefanamic Acid
* Drug: Valproate


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |