Study of absorption and elimination rate of Atorvastatin 40 mg tablets in comparison with standard tablets of Atorvastatin (Lipitor®).

Randomized, single-dose, crossover comparative bioequivalence study of the Atorvastatin 40 mg tablets produced by Daana pharmaceutical Co versus Lipitor® (Pfizer company) in 24 healthy males under fasting conditions

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200407046981N16

Enrollment

Registered

2021-09-14

Start date

2021-10-02

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Bioequivalence study.

Interventions

Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Atorvastatin 40 mg tablet produced by Daana Co. (Domestic). After the washout period, the volunteers are

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The weight limit for each volunteer is between 60 and 100 kg. All volunteers must be non-smokers. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.

Exclusion criteria

Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Atorvastatin or any ingredients. Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing.

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 and48 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).	—

Secondary

Measure	Time frame
AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before dosing), 0.5? 1? 1.5? 2? 2.5? 3? 3.5? 4? 6? 8? 10? 12? 24 and 48 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hamed Hamishehkar

Tabriz University of Medical Sciences

Hamishehkar.hamed@gmail.com+98 41 3336 7914

Outcome results

None listed

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