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Interventional, randomized, single dose, open-label, crossover, bioequivalence study in healthy men and women to compare two pharmaceutical formulations of flupentixol/melitracen (Deanxit) – in fasted and fed conditions

Interventional, randomized, single dose, open-label, crossover, bioequivalence study in healthy men and women to compare two pharmaceutical formulations of flupentixol/melitracen (Deanxit) – in fasted and fed conditions

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015990
Enrollment
Unknown
Registered
2018-05-04
Start date
2018-05-04
Completion date
Unknown
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antipsychotics

Interventions

A1 Group (T-R):T-R in fast condition
A1 Group (R-T):R-T in fast condition
A2 Group (T-R):T-R in fed condition
A2 Group (R-T):R-T in fed condition

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. The subject is able to read and understand the Subject Information Sheet and Informed Consent Form; 2. The subject has signed the study-specific Informed Consent Form; 3. The subject is a man or woman can follow specific contraceptive measures . 4. The subject is >18 and 50 and 45 bpm; 7. The subject has a resting systolic blood pressure >91 and <140 mmHg and a resting diastolic blood pressure 51 and 90 mmHg at the Screening Visit and at the Baseline Visit; 8. The subject has a normal circadian rhythm; 9. The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion criteria

Exclusion criteria: 1. The subject has taken disallowed medication 21 units per week for men or >14 units per week for women, or substance use (excluding nicotine or caffeine) deemed significant by the investigator, or a history of substance abuse (DSM-5? criteria) 5 years prior to the first dose of IMP; 9. The subject has had major surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) 5 times per day; 18. The subject has tested posi

Design outcomes

Primary

MeasureTime frame
Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical;

Countries

China

Contacts

Public ContactXinghe Wang

Beijing Shijitan Hospital Capital Medical University

wangxinghe@yahoo.com+86 10 63926401

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026