Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate
- Registration Number
- NCT05181007
- Lead Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Brief Summary
study the effect of mefanamic acid or valproate on ciprofol
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MFA Mefanamic Acid mefanamic acid VPA Valproate valproate
- Primary Outcome Measures
Name Time Method effect of mefanamic acid on the Cmax of ciprofol 0-24hour post ciprofol dosing Peak Plasma Concentration (Cmax)
effect of mefanamic acid on the AUC of ciprofol 0-24hour post ciprofol dosing Area under the plasma concentration versus time curve (AUC)
effect of valproate on the Cmax of ciprofol 0-24hour post ciprofol dosing Peak Plasma Concentration (Cmax)
effect of valproate on the AUC of ciprofol 0-24hour post ciprofol dosing Area under the plasma concentration versus time curve (AUC)
- Secondary Outcome Measures
Name Time Method Safety when ciprofol is co-administered with mefanamic acid or valproate 0-24hour post ciprofol dosing Adverse event
effect of mefanamic acid or valproate on the MOAA/S of ciprofol 0-24hour post ciprofol dosing MOAA/S
effect of mefanamic acid or valproate on the BIS of ciprofol 0-24hour post ciprofol dosing BIS
Trial Locations
- Locations (1)
The second affiliated hospital Zhejiang University School of Medicine
🇨🇳Hanzhou, China
The second affiliated hospital Zhejiang University School of Medicine🇨🇳Hanzhou, China