None listed
Conditions
Brief summary
In the present study the bioequivalence of three different drugs, the same type of pharmaceutical form at the same dose, containing the same drug (atorvastatin), but may have different excipients was evaluated. Compared if their plasma pharmacokinetic parameters, expressed as area under curve from time zero to the last measurement (AUC0-t); area under curve from time zero to infinity (AUC0-8); maximum plasma concentration (Cmax); and time to peak plasma concentration is reached (Tmax), have similarity to each other. In 60 healthy male non-smoking volunteers, bioequivalence of drugs R (reference), Test 1 (T1) and test 2 (T2) was evaluated through a design WILLSON 3 periods, 3 treatments and 6 sequences. The analysis of plasma levels of atorvastatin was performed by extracting the proteins and subsequent quantification by HPLC/MS-MS in a concentration range of: 0.5 to 100 ng/mL. The Atorvastatina/A95-10Bis study was conducted in a timely and manner required. Adverse effects: No adverse reactions occurred during, and after the end of the clinical protocol. Clinical protocol deviations: There were no clinical protocol deviations. Selection of subjects: All volunteers included in the study successfully met the criteria for selection and inclusion. It is established that drugs test T1 and T2 in the same substance atorvastatin, are bioequivalent.
Interventions
Test 1: Atorvastatin 80 mg coated tablets.
Test 2: Atorvastatin 80 mg tablets.
Treatment is with a single daily dose of 80 mg of Atorvastatin via oral administration. Three treatments (single dose), 3 periods (one day per period) and two-week washout between each period for the removal of the previous dose.
At least 72 hours before the time fixed for the study, the volunteer will receive in writing the appropriate citation where the place, date and time of the baseline is established. As the
Test 1: Atorvastatin 80 mg coated tablets. Test 2: Atorvastatin 80 mg tablets. Treatment is with a single daily dose of 80 mg of Atorvastatin via oral administration. Three treatments (single dose), 3 periods (one day per period) and two-week washout between each period for the removal of the previous dose. At least 72 hours before the time fixed for the study, the volunteer will receive in writing the appropriate citation where the place, date and time of the baseline is established. As the following notes for the week before the study: No Smoking (passively, as they are not smokers), not drink alcohol, do not consume xanthine beverages (cola, coffee, tea, chocolate, etc.) not consume grapefruit natural juice, not eating grilled food, do not use any other drug from the week before the study. Each volunteer will be welcomed by doctors and nursing staff involved in the study and they ask about the indications received 72 hours prior. They will be placed in facilities Ipharma SA de CV, will receive a light dinner (less than 800 kcal), low residue. You can drink water until 10:00 PM. Will rise at the time indicated by the staff in the clinical area and take a bath. A member of staff will move to room 1 and 2 as appropriate to randomization. Each subject will be assigned to three experimental units EU, one for each trial period, so that 01 to 60 is for the period 1 (P1) and 61 to 120 at period 2 (P2) and 121 to 180 for the period 3 (P3). The staff of each experimental unit consists of nurses, doctors, staff quality area, support staff; as well as the principal investigator. Each subject will be placed a catheter (Inthracat or equivalent) in the vein of the elbow, they made the decision at time 0 and after this will be administered the drug orally under the supervision of physicians. After drug administration the blood samples were obtained at different times by the staff Ipharma, these will be recorded in the logs corresponding times, will be delivered to preparation laboratory of the Institute for registration, processing and storage. After about four hours after drug administration, volunteers will be provided fruit and 500 ml sports drink. From about 5 hours may drink water. After about 8 hours Administration medication, a light lunch will be provided to volunteers. After about 12 hour’s administration, they will provide a light dinner volunteers. After taking 24 hours corresponding sample were withdrawn venous catheter and volunteers remain another hour in the Institute. The proof of this first period will terminate after the last blood sample. The procedure will be similar for periods 2 and 3, with the only difference of treatment allocation, as appropriate to randomization. At the time of the study and throughout the sampling period will perform a general physical examination protocol including vital signs at the beginning, during and at the end of each period, allowing us to detect the most common adverse effects such as: hypersensitivity, rash, cardiopulmonary complications, etc. Post-experimental phase All volunteers will be interviewed one week after the third period. These interviews will be questioned about possible side effects voluntary late onset. The information gathered will be recorded in their records.
Sponsors
Ipharma S. A. de C.V.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Outcome results
None listed