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Completed

NCT Number: NCT05181007

Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate

study the effect of mefanamic acid or valproate on ciprofol

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The second affiliated hospital Zhejiang University School of Medicine

Hanzhou, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Mefanamic Acid

Drug

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

Valproate

Drug

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

Primary outcomes

  1. effect of mefanamic acid on the Cmax of ciprofol

    Time frame: 0-24hour post ciprofol dosing

    Peak Plasma Concentration (Cmax)

  2. effect of mefanamic acid on the AUC of ciprofol

    Time frame: 0-24hour post ciprofol dosing

    Area under the plasma concentration versus time curve (AUC)

  3. effect of valproate on the Cmax of ciprofol

    Time frame: 0-24hour post ciprofol dosing

    Peak Plasma Concentration (Cmax)

  4. effect of valproate on the AUC of ciprofol

    Time frame: 0-24hour post ciprofol dosing

    Area under the plasma concentration versus time curve (AUC)

Secondary outcomes

  1. Safety when ciprofol is co-administered with mefanamic acid or valproate

    Time frame: 0-24hour post ciprofol dosing

    Adverse event

  2. effect of mefanamic acid or valproate on the MOAA/S of ciprofol

    Time frame: 0-24hour post ciprofol dosing

    MOAA/S

  3. effect of mefanamic acid or valproate on the BIS of ciprofol

    Time frame: 0-24hour post ciprofol dosing

    BIS

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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