bioequivalence study of Escitalopram 10 mg film-coated tablets in 18 healthy male under fasting conditions

Randomized, single-dose, crossover comparative bioequivalence study of Escitalopram 10 mg film-coated tablets of Actoverco. and Lundbeck Limited Co. in 18 healthy male under fasting conditions

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N5

Enrollment

Registered

2021-01-05

Start date

2019-11-30

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Bioequivalence investigation of the generic (Actoverco.) Escitalopram 10 mg tablet with brand (Cipralex ) Lundbeck Limited 10 mg tablet..

Interventions

Intervention 1: Intervention group: (test): Escitalipram 10 mg tablet, produced by Actoverco. is the test product. In each period, 9 of 18 subjects will be given single oral dose of this product. Inte

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5-30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects with normal ECG and vital signs. Subjects who agree with patient consent form.

Exclusion criteria

Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Escitalopram or inactive Allergy to any medication, substance, or food. History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, any kind of anemia, asthma, and mental disease. Muscular trauma 21 days before the beginning of the study. Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study and might need drug intake during study period. Subjects who have a history of alcohol or substance abuse within the last 5 years

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Secondary

Measure	Time frame
AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Aghaei

Noor Research & Development Institute

info@tavaninstitute.ir+98 21 6600 4027

Outcome results

None listed

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