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Pharmacokinetics and Bioavailability Comparison of 20-mg generic and branded Citalopram Tablets: An Open-label, Randomized Sequence, Two-Period Crossover Study in Healthy Chinese CYP2C19 Extensive Metabolizers

Pharmacokinetics and Bioavailability Comparison of 20-mg generic and branded Citalopram Tablets: An Open-label, Randomized Sequence, Two-Period Crossover Study in Healthy Chinese CYP2C19 Extensive Metabolizers

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12001893
Enrollment
Unknown
Registered
2012-01-18
Start date
2007-12-28
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

Major depression

Interventions

2:citalopram 20-mg tablets

Sponsors

Sandoz International GmbH
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 32 Years

Inclusion criteria

Inclusion criteria: age 18 to 40 years; body mass index between 20 and 24 kg/m2; and CYP2C19 genotype of *1/*1, *1/*2, or *1/*3

Exclusion criteria

Exclusion criteria: smoking; the presence of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, hematological, metabolic, or mental diseases; a history of drug hypersensitivity and psychotropic drug treatment; and current pharmacologic treatment (including over-the-counter remedies) 2 weeks before or during the study period.

Design outcomes

Primary

MeasureTime frame
pharmacokinetic property;—

Countries

China

Contacts

Public ContactHongzhuan Chen
Hongzhuan_Chen@hotmail.com+86 21 63846590-776451

Outcome results

None listed

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