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Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate

Haisco Pharmaceutical Group logo

Haisco Pharmaceutical Group

Status and phase

Completed
Phase 1

Conditions

Drug Drug Interaction

Treatments

Drug: Valproate
Drug: Mefanamic Acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT05181007
HSK3486-111

Details and patient eligibility

About

study the effect of mefanamic acid or valproate on ciprofol

Enrollment

41 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

41 participants in 2 patient groups

MFA
Active Comparator group
Description:
mefanamic acid
Treatment:
Drug: Mefanamic Acid
VPA
Active Comparator group
Description:
valproate
Treatment:
Drug: Valproate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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