Bioequivalence of Zidovudine

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000263
• Date of registration: 29/11/2017
• Prospective Registration: Yes
• Primary sponsor: Center for Pharmaceutical Research and Development, Havana, Cuba.
• Public title: Bioequivalence of Zidovudine
• Scientific title: Bioequivalence study of Zidovudine tablets (300 mg) in HIV+ patients
• Date of first enrolment: 03/01/2018
• Target sample size: 30
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000263-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Crossover. Purpose: Treatment
• Phase: 1

Countries of recruitment

Cuba

Contacts

• Name: Idrian Garcia Garcia
• Affiliation: Center for Pharmaceutical Research and Development

• Name: Idrian Garcia Garcia
• Affiliation: Center for Pharmaceutical Research and Development

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 50 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Immune System Diseases

Sexually Transmitted Diseases, Viral

Patients seropositive to Human Immunodeficiency Virus (HIV)

HIV Infections

Immunologic Deficiency Syndromes

RNA Viruses Infections

Sexually Transmitted Diseases

Lentiviruses Infections

Retroviridae Infections

Virus Diseases

Intervention(s)

Zidovudine

Tablets

Single Dose

Administration, Oral

Retrovir

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.

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.

Secondary Outcome(s)

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.

Secondary ID(s)

Code: BB/06/16

Source(s) of Monetary Support

Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Pharmaceutical Laboratories NOVATEC, Company MEDSOL, BioCubaFarma, Havaan, Cuba.