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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05181007

Enrollment

Registered

2022-01-06

Start date

2021-12-17

Completion date

2022-06-01

Last updated

2022-07-14

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

Conditions

Drug Drug Interaction

Brief summary

study the effect of mefanamic acid or valproate on ciprofol

Interventions

DRUGMefanamic Acid

mefanamic acid once every 6 hours on Day 4 and Day 5, Ciprofol on Day 1 and Day 5

DRUGValproate

valproate once daily on Day 4 to Day 8, Ciprofol on Day 1 and Day 8

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Safety when ciprofol is co-administered with mefanamic acid or valproate	0-24hour post ciprofol dosing	Adverse event

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026