bioequivalence study of Levodopa 200 mg + Benserazide 50 mg tablets in 24 healthy male under fasting conditions

Randomized, single-dose, crossover comparative bioequivalence study of Levodopa 200 mg + Benserazide 50 mg tablets of Abian Pharmed Co. and ROCHE in 24 healthy male under fasting conditions

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N6

Enrollment

Registered

2021-08-14

Start date

2021-07-31

Completion date

Unknown

Last updated

2021-08-30

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 Abian Pharmed Co. Levodopa 200 mg + Benserazide 50 mg tablet with brand MADOPAR ROCHE tablet..

Interventions

Intervention 1: Intervention group: (test): Levodopa 200 mg + Benserazide 50 mg tablet, produced by Abian Pharmed Co. is the test product. In each period, 12 of 24 subjects will be given single oral d

Eligibility

Sex/Gender

Male

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy subjects (male) between 20– 45years 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 vital signs. Subjects who agree with patient consent form.

Exclusion criteria

Exclusion criteria: Subjects with known allergy to the products tested. History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period; Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period; History of alcohol or drug abuse within 2 years before the start of the study;

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