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Pharmacokinetics and Bioequivalence study of Hydrochloride Terazosin Capsules in Healthy Chinese Volunteers

Comparative bioavailability of Terazosin capsule in healthy Chinese volunteers: an open-label, randomized, single-dose, 2-way crossover study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041775
Enrollment
Unknown
Registered
2021-01-05
Start date
2020-02-21
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

cardiovascular disorders

Interventions

Group C:fed state T-R
Group D:fed state R-T

Sponsors

People's Hospital of Deyang City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Subjects should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent; 2. Subjects Can communicate well with the researchers, understand and comply with the requirements of the entire study; 3. Aged 18 to 45 years (including 18 and 45 one full year of life), both men and women; 4. Male subjects with weight more than 50 kg (contain 50 kg), female subjects with weight more than 45 kg (including 45 kg); Body mass index [BMI = weight (kg)/height (m) 2] within the scope of the 19 ~ 26 kg/m2; 5. According to past medical history, comprehensive physical examination and laboratory test, the researchers identified as healthy subjects; 6. Subjects should take effective appropriate precautions 3 months after the study.

Exclusion criteria

Exclusion criteria: 1. Have allergic history. Subjects allergic to two or more medicines, food and pollen or ingredients of investigator product; 2. Have history of needlesickness, Hematophobia and known severe hemorrhagic trend; 3. Have difficulty of swallowing or can't tolerate venipuncture; 4. Subjects have special requirements on diet and cannot tolerate high-fat diet; 5. Resting heart rate 100 beats/min (only one retest result is acceptable); 6. SBP >= 140 mmHg or = 90 mmHg or 1.5 ULN, CREA > ULN; 23. Poor adherence or unsuitable to participate in the trial considered by the researchers.

Design outcomes

Primary

MeasureTime frame
Cmax;Tmax;AUC0-t;AUC0-8;t1/2;

Countries

China

Contacts

Public ContactFan Lianlian

People's Hospital of Deyang City

510791761@qq.com+86 13548265614

Outcome results

None listed

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