Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-17

Study Completion Date

2022-06-01

Brief Summary

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study the effect of mefanamic acid or valproate on ciprofol

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Detailed Description

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Conditions

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Drug Drug Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MFA

mefanamic acid

Group Type ACTIVE_COMPARATOR

Mefanamic Acid

Intervention Type DRUG

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

VPA

valproate

Group Type ACTIVE_COMPARATOR

Valproate

Intervention Type DRUG

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

Interventions

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Mefanamic Acid

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

Intervention Type DRUG

Valproate

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

Intervention Type DRUG

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes