--- title: Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Participants nct_id: NCT03220867 overall_status: WITHDRAWN phase: PHASE1 sponsor: Xian-Janssen Pharmaceutical Ltd. study_type: INTERVENTIONAL primary_condition: Healthy countries: China canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03220867.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03220867" ct_last_update_post_date: 2018-02-28 last_seen_at: "2026-05-12T07:19:06.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Participants **Official Title:** A Single-Dose, Randomized, Open-Label, Two-Treatment, Two-Period, Two-Cohort, Crossover Study to Assess the Bioequivalence of Xian Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Subjects Compared With Gurabo Risperdal Tablets **NCT ID:** [NCT03220867](https://clinicaltrials.gov/study/NCT03220867) ## Key Facts - **Status:** WITHDRAWN - **Why Stopped:** CFDA announced Xi'An Risperdal as reference drug, no need for this BE trial from both scientific and ethical perspective. - **Phase:** PHASE1 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 0 - **Lead Sponsor:** Xian-Janssen Pharmaceutical Ltd. - **Conditions:** Healthy - **Start Date:** 2017-12-11 - **Completion Date:** 2018-04-27 - **CT.gov Last Update:** 2018-02-28 ## Brief Summary The primary purpose of this study is to assess the bioequivalence of Xian Risperdal compared with Gurabo Risperdal in Chinese healthy participants under fasting and fed conditions. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 55 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: * Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study and adhere to the prohibitions and restrictions specified in this protocol * If a woman, must have a negative serum pregnancy test at screening and on Day -1 of each treatment period * If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug * Body mass index (BMI), weight (kilogram \[kg\])/height\^2 (meter \[m\]\^2) between 19.0 and 28.0 kg/m\^2, inclusive; body weight not less than 50 kg * After being supine for 5 minutes, systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive; diastolic blood pressure between 60 and 90 mmHg, inclusive; heart rate between 50 and 100 beats per minute (bpm), inclusive Exclusion Criteria: * Presence of orthostatic hypertension at screening, defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg compared to supine position when the participant assumes a standing position * Positive test for drug screening, such as cannabinoids, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates on Day -1 of each treatment period * Drug abusers or use of soft drugs (example \[eg\], cannabis) within 3 months prior to the study or hard drugs (eg cocaine, benzene cyclohexylidene, etc.) within 1 year prior to the study * Received an experimental drug or used an experimental medical device within 3 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled * Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C antibodies or syphilis serum test ``` ## Arms - **Treatment Sequence: AB** (EXPERIMENTAL) — Participants in cohort 1 (fasting) and cohort 2 (fed) will receive 1 milligram (mg) risperidone administered as Xian Risperdal (test) 1\*1 mg oral tablet (Treatment A) on Day 1 in Period 1 followed by 1 mg risperidone administered as Gurabo Risperdal (reference) 1\*1 mg oral tablet (Treatment B) on Day 1 in period 2. There will be a washout period of at least 10 days between treatments. - **Treatment Sequence: BA** (EXPERIMENTAL) — Participants in cohort 1 (fasting) and cohort 2 (fed) will receive Treatment B on Day 1 in period 1 followed by Treatment A on Day 1 in period 2. There will be a washout period of at least 10 days between treatments. ## Interventions - **Risperidone: Xian Risperdal (test)** (DRUG) — Participants will receive 1\*1 mg tablet of Xian Risperdal under fasting or fed condition. - **Risperidone: Gurabo Risperdal (reference)** (DRUG) — Participants will receive 1\*1 mg tablet of Gurabo Risperdal under fasting or fed condition. ## Primary Outcomes - **Maximum Observed Plasma Concentration (Cmax)** _(time frame: Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose)_ — Maximum observed plasma concentration (Cmax) will be assessed. - **Area Under Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last])** _(time frame: Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose)_ — Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation. - **Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])** _(time frame: Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose)_ — The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. AUC (0-infinity) will be assessed. ## Secondary Outcomes - **Number of Participants With Adverse Events as a Measure of Safety and Tolerability** _(time frame: Up to approximately 29 days)_ ## Locations (1) - Beijing Shijitan Hospital, Beijing, China ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.beijing shijitan hospital|beijing||china` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03220867.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03220867* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*