Bioequivalence of Zidovudine

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Bioequivalence study of Zidovudine tablets (300 mg) in HIV+ patients

Secondary indentifying numbers:

Code: BB/06/16

Issuing authority of the secondary identifying numbers:

Center for Pharmaceutical Research and Development, Havana, Cuba.

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Lizette

Last name:

Gil del Valle

Medical Specialty :

Bachelor in Biochemistry, PhD in Pharmaceutical Sciences.

Affiliation:

Institute of Tropical Medicine "Pedro Kouri” (IPK)

Postal address:

"Novia del Mediodia" Highway, Km 6 1/2. La Lisa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72553236

+53-72553234

Email address:

lgil@ipk.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Institute of Tropical Medicine "Pedro Kouri”, Havana, October 25, 2016.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

03/01/2018

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Patients seropositive to Human Immunodeficiency Virus (HIV)

Health condition(s) code:

HIV

HIV Infections

Lentiviruses Infections

Retroviridae Infections

RNA Viruses Infections

Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Virus Diseases

Intervention(s):

Group Zidovudine and then Retrovir®: Patients will receive a unique dose of 300 mg (a tablet) of Zidovudine by oral route between 8:00 and 9:00am. After a washout period of 7 days, they will receive a unique dose of 30 0mg (a tablet) of Retrovir® by oral route between 8:00 and 9:00am too. Group Retrovir® and then Zidovudine: Patients will receive a unique dose of 300 mg (a tablet) of Retrovir® by oral route between 8:00 and 9:00am. After a washout period of 7 days, they will receive a unique dose of 30 0mg (a tablet) of Zidovudine by oral route between 8:00 and 9:00am too.

Intervention code:

Zidovudine

Tablets

Administration, Oral

Single Dose

Intervention keyword:

Retrovir

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Pharmacokinetic variable - Plasma levels of Zidovudine (values expressed in mcg/mL): Measuring time: At the beginning and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after administration.

Key secondary outcomes:

Presence of adverse events-AE - distribution frequency for the appearance of adverse events (Yes, No), - type of event (name of the AE), - duration (time from appearance to end of the event), - severity (severe, non-severe), - intensity of AE (grades 1-5), - causal relationship (remote, possible, probable, very probable), - result of AE (recuperate, improvement, persist or sequels), - attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation)). Measuring time: At each administration and during the whole study. Clinical laboratory tests - Hematology (hemoglobin, hematocrit, white blood cells counts, globular sedimentation rate, platelet count) and - Biochemistry (glycemia, cholesterol, triglycerides, transaminases, alkaline phosphatase, urea, creatinine) determinations (numerical values as units of measurement for each determination). Measuring time: At baseline and end of the study. - Vital signs (body temperature in degrees centigrade, heart rate in beats / minute, blood pressure in mm Hg and respiration rate in breaths per minute). Measuring time: Prior to administration of the tablets, during the first 4 hours after administration, and at the end of each period.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

50 years

Inclusion criteria:

1- HIV-positive patients diagnosed with two Western Blot tests positive (at least two HIV envelope proteins) which are covered by the sanatorium system or Ambulatory Care System (SAA). 2- Written informed consent. 3- Aged between 18-50 years. 4- Patients from any gender. 5- Patient’s weight: +/- 15% of ideal weight for height. 6- Not have evidence or history of diseases such as bronchial asthma, peptic or duodenal ulcer, liver failure, kidney failure, severe allergic reactions, atopic dermatitis, cardiovascular disorders, diabetes mellitus. 7- No opportunistic infections at the onset of the study. 8- Satisfactory physical examination. 9- Do not be ingesting medication at the time of the study or in the 15 days before the start of it. 10- Present vital signs values within the following reference ranges. Systolic blood pressure between 90 and 130 mm Hg and diastolic blood pressure between 60 and 80 mm Hg, heart rate between 60 to 100 beats per minute, respiratory rate between 12 to 20 breaths per minute. 11- Not having consumed alcohol, drinks containing xanthines (tea, coffee, and cola) and carbonated beverages three days before the start of each period and during it. 12- Patients of childbearing potential must use effective contraception up to three months after completion of treatment.

Exclusion criteria:

1- Pregnancy and / or breastfeeding. 2- Previous antiretroviral treatment or current criteria for antiretroviral therapy treatment. 3- Post-menopausal women (age 45 or older with at least two years of amenorrhea) or documented history of hysterectomy and / or annexectomy double sex. 4- Known history of allergies or drug, or to any component of the formulations studied (at the discretion of the investigator) hypersensitivity. 5- Refer viral disease in the last 7 days. 6- To be ingesting some medication 15 days (or for 5 half-lives) before the first dose of product research or nonprescribed or free drugs (OTC drugs) or herbal medicines / dietary supplements in a period seven days before the first dose of research products until the end of the study. 7- Serum creatinin values higher than 1.5 times the upper limit of the reference range. 8- Values of AST and ALT higher than 2 times the upper limit of the reference range. 9- Positive for hepatitis B and C and serology results. 10- History of alcoholism in the past 6 months (not less consumption ¼ bottle of rum or one (1) bottle of wine or three (3) beers in a higher frequency of twice a week. 11- Patients with a history of drug consumption dependence or drug abuse. 12- To be undergone major surgery within 6 months prior to baseline.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Crossover

Phase:

1

Target sample size:

30

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Idrian

Last Name:

Garcia Garcia

Specialty:

PhD in Health Sciences. Bachelor in Pharmaceutical Sciences. Master in Experimental Pharmacology..

Affiliation:

Center for Pharmaceutical Research and Development

Postal Address:

Ave.26 and Calzada de Grandes Puentes. # 1605, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+537-8811944 ext. 144.

Email :

idrian.garcia@cidem.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Idrian

Last Name:

Garcia Garcia

Specialty:

PhD in Health Sciences. Bachelor in Pharmaceutical Sciences. Master in Experimental Pharmacology.

Affiliation:

Center for Pharmaceutical Research and Development

Postal Address:

Ave. 26 and Calzada de Grandes Puentes, # 1605, Plaza de la Revolucion.

City:

10600

País:

Havana

Zip Code:

Cuba

Telephone:

+537-8811944 ext. 144.

Email :

idrian.garcia@cidem.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000263

Date of Registration in Primary Registry:

29/11/2017

Record Verification Date:

2017/11/29

Next update date:

2018/11/29

Link to the spanish version:

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Versión para impresión

Ensayos Registrados

Proceso de Registro

Bioequivalence of Zidovudine

Acerca del RPCEC

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