Bioequivalence study of three pharmaceutical preparations Atorvastatin tablets.Crossover, randomized, single-dose, three-treatment, three periods and six strings under fasting conditions

Phase 1

Completed

• Registration Number: ACTRN12614000851662
• Lead Sponsor: Ipharma S. A. de C.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Will be included only those male volunteers who approve the clinical assessment by Ipharma physician’s and pass the clinical biochemistry tests, such as: hematic biometry, blood chemistry, lipid profile and liver function. As well as the absence of any evidence of chronic degenerative disease, and compliant with the following criteria:
-Non-smokers
-18 to 45 years old
- Males
- Body mass index of 20 to 26 Kg/m2

Exclusion Criteria

Were excluded from the study those who had electrocardiographic, radiologic abnormalities, which were VDRL (+), HIV (+) and / or HBsAg (+); relatives who had angioedema or allergies to medication, chemically related to drugs and generally any allergies or medical history, as these people have a higher risk of drug allergies. Also lead to exclusion of smoking habits and / or addiction, as well as those who were subject to medical treatment; the existence of concurrent or intercurrent disease and those where there was reasonable doubt about the veracity of the answers in the interview. Finally, all those volunteers who were discordant with the Official Mexican Standard NOM-177-SSA1-1998 were excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified