In- Vivo Bioequivalence study of Atorvastatin tablets 40 mg Kharazmi Pharma with brand drugs (LIPITOR® 40 mg, Pfizer, Germany) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N72

Enrollment

Registered

2023-01-29

Start date

2022-12-30

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Bio equivalence test.

Interventions

Intervention 1: Intervention group 1: Single dose, one oral Atorvastatin 40 mg tablet manufactured by Kharazmi pharmaceutical company as a test product. Intervention 2: Single dose, one oral Lipitor

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-55 years old

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: Sampling times in this study will be 0? 0.5? 0.75? 1? 1.5? 2? 2.5? 0?3? 4? 5? 6? 8? 10? 12? 24? 48 ,72 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDariush Omidfar

Simin Baspar Teyf Gostar Company

Dariush.omidfar@gmail.com+98 41 3384 2724

Outcome results

None listed

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