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Bioequivalence study of two Escitalopram 20 mg FC Tablet manufactured by tadbir kalaye jam company

Bioequivalence study of two Escitalopram 20 mg FC Tablet manufactured by tadbir kalaye jam company in comparison with Brand

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240803062623N1
Enrollment
24
Registered
2024-10-09
Start date
2024-11-05
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

This study is performed on healthy volunteers and drug concentration in plasma is determined..

Interventions

Intervention 1: Intervention group: single dose, one oral tablets (Cipralex 20 mg, Lundbeck) as a reference product. after washout period, the volunteers received Escitalopram 20 mg FC Tablet manufac

Sponsors

Tadbir Kala Jam
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) Informed consent Age (18-40years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Escitalopram

Design outcomes

Primary

MeasureTime frame
Drug plasma concentration. Timepoint: 0, 1, 2, 3, 3/5, 4, 4/5, 5, 5/5, 6, 6/5, 7, 8, 9, 10, 11, 12, 24, 36, 48 h after drug administration. Method of measurement: Liquid chromatography–mass spectrometry.

Secondary

MeasureTime frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Ali Karkhaneh Yousefi

Tadbir Kalaye Jam co.

yousefi@tadbirkala.com+98 21 8866 8700

Outcome results

None listed

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