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Bioequivalence study of irbesartan hydrochlorothiazide tablet (300/12.5mg) in human

Bioequivalence study of irbesartan hydrochlorothiazide tablet (300/12.5mg) in human

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-OTRCC-12003517
Enrollment
Unknown
Registered
2012-06-06
Start date
2012-06-06
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

hypertension

Interventions

Group A:taking the reference formulation first, then taking the test preparation
Group B:taking the test preparation first, then taking the reference formulation

Sponsors

The first affiliated hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 27 Years

Inclusion criteria

Inclusion criteria: (1) The healthy male; (2) Aged 18 ~ 40 years old, with a group of subjects no younger than 10 years of age; (3) The weight is higher than 50kg, body mass index (BMI) in the context of 19-25 kg/m2, [BMI= weight (kg)/height (m2)]; (4) Communicate well with the researchers and comply with the requirements of the entire study; (5) Fully understand the purpose, methods, and possible reactions of the trial, volunteered to participate in the trial and sign a informed consent form.

Exclusion criteria

Exclusion criteria: (1) Allergy somatoplasm, such as allergy to two or more drugs, foods and pollen; or known allergy to the components of the drug or Analogues; (2) Participated in other clinical trials within three months; (3) Donated blood within one month, or plan to donate blood during the trial or within 1 month at the end of the trial; (4) Used the test of reference drug within two week; (5) Volunteers who had a history of a cardiac, hepatic, renal, gastrointestinal, nervous system, psychiatric or metabolic abnormality; (6) The general examination and blood pressure, heart rate and respiratory conditions did not meet with standards; (7) Any significant clinical disease symptoms during physical examination revealed; (8) Laboratory tests (blood and urine routine, liver and kidney function, ECG and HIV et. al) found hematological abnormalities, heart, liver and kidney dysfunction; (9) Drug abusers, alcohol and smoke addiction; (10) Unsuitable to participate in the trial considered by the researchers.

Design outcomes

Primary

MeasureTime frame
AUC0-t;Cmax;

Contacts

Public ContactJianzhong Shen-tu

The first affiliated hospital, School of Medicine, Zhejiang University

stjzcn@aliyun.com+86 571 87236560

Outcome results

None listed

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