CompletedNot Applicable

Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans

China72 participantsStarted 2023-05-24

Plain-language summary

The test formulation of Nalfurafine Hydrochloride Orally Disintegrating Tablets (2.5 μg) is bioequivalent to the reference formulation (Remitch®) in healthy Chinese subjects under fed conditions.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntarily participate and sign the informed consent form, with the informed consent process complying with GCP requirements;
✓. Healthy male or female;
✓. Aged 18 years or older;
✓. Female body weight ≥45.0 kg, male body weight ≥50.0 kg, with body mass index (BMI) = weight (kg) / height² (m²), and BMI within the range of 19.0-26.0 kg/m², inclusive.

Exclusion criteria

✕. A history or current presence of abnormalities in the motor system, nervous system, mental system, endocrine system, blood circulation system, respiratory system, digestive system, urinary system, or reproductive system, which is deemed clinically significant by the investigator;
✕. Undergone surgery within 3 months prior to screening or during the screening period, or undergone surgery that affects drug absorption, distribution, metabolism, or excretion, or planned surgery during the study period;
✕. A history of habitual constipation;
✕. Chronic insomnia or a habit of taking sleeping pills;
✕. Blood donation or significant blood loss (≥400 mL) within 3 months prior to screening or during the screening period (excluding physiological blood loss in women);
✕. A history of drug abuse within the past 5 years or a positive result in drug screening;
✕. A specific allergy history (asthma, urticaria, eczema, etc.), or allergies to drugs, environments, foods, or known allergy to the components or analogs of this drug;
✕. Excessive consumption of tea, coffee, or caffeinated beverages within 3 months prior to screening (more than 8 cups per day, 1 cup = 250 mL), or intake of any food or beverage containing alcohol, caffeine, or xanthine-rich substances (such as coffee, strong tea, chocolate, cola, grapefruit, etc.) within 48 hours before taking the investigational drug;

What they're measuring

Peak Plasma Concentration (Cmax)

Timeframe: 36 hours post-dose in each period

Area under the plasma concentration versus time curve (AUC) 0-t

Timeframe: 36 hours post-dose in each period

Area under the plasma concentration versus time curve (AUC)0-∞

Timeframe: 36 hours post-dose in each period

Trial details

NCT IDNCT07478133

SponsorShandong New Time Pharmaceutical Co., LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-14

View on ClinicalTrials.gov More Pruritus trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntarily participate and sign the informed consent form, with the informed consent process complying with GCP requirements;
✓. Healthy male or female;
✓. Aged 18 years or older;
✓. Female body weight ≥45.0 kg, male body weight ≥50.0 kg, with body mass index (BMI) = weight (kg) / height² (m²), and BMI within the range of 19.0-26.0 kg/m², inclusive.

Exclusion criteria

✕. A history or current presence of abnormalities in the motor system, nervous system, mental system, endocrine system, blood circulation system, respiratory system, digestive system, urinary system, or reproductive system, which is deemed clinically significant by the investigator;
✕. Undergone surgery within 3 months prior to screening or during the screening period, or undergone surgery that affects drug absorption, distribution, metabolism, or excretion, or planned surgery during the study period;
✕. A history of habitual constipation;
✕. Chronic insomnia or a habit of taking sleeping pills;
✕. Blood donation or significant blood loss (≥400 mL) within 3 months prior to screening or during the screening period (excluding physiological blood loss in women);
✕. A history of drug abuse within the past 5 years or a positive result in drug screening;
✕. A specific allergy history (asthma, urticaria, eczema, etc.), or allergies to drugs, environments, foods, or known allergy to the components or analogs of this drug;
✕. Excessive consumption of tea, coffee, or caffeinated beverages within 3 months prior to screening (more than 8 cups per day, 1 cup = 250 mL), or intake of any food or beverage containing alcohol, caffeine, or xanthine-rich substances (such as coffee, strong tea, chocolate, cola, grapefruit, etc.) within 48 hours before taking the investigational drug;