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Bioequivalence test of Citalopram in Chinese healthy subjects

Bioequivalence test of Citalopram in Chinese healthy subjects

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001533
Enrollment
Unknown
Registered
2011-07-19
Start date
2011-05-06
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

tristimania

Interventions

A:hydrogen bromate citalopram piece
B:citalopram piece (Ti ni you ding)

Sponsors

Henan Province People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. normal subjects of general weight should be no less than 45 kg, according to body mass index calculation, generally in the standards body mass index (18 to 24) range; 2. Comprehensive physical examination including general medical examination, laboratory tests on an empty stomach, liver and kidney function (routine blood, urine, etc.), electrocardiogram (ecg all normal; 3.No tobacco hobby; 4. At least four weeks is not taking any other drugs.

Exclusion criteria

Exclusion criteria: 1.There is evidence to show that subjects drug abuse; 2. Daily smokers more than 5 cigarettes or the same amount of tobacco; 3.Research by 1 h in 48 alcoholic or caffeinated beverages; 4.Participants understand, exchanges and cooperation is not enough, can't guarantee according to plan the researchers; 5. The researchers think that don't fit for test of the other factors.

Design outcomes

Primary

MeasureTime frame
dynamics index;

Countries

China

Contacts

Public ContactYuHua Qin

National Clinical Pharmacology Research Base of Henan province people's hospital

qyh@163.com+86 0371 65580366

Outcome results

None listed

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