- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01469520
Bioequivalence Study of Pediatric Formulations to Treat HIV Infection
Phase I Three-way Crossover Bioequivalence Study of Pediatric Formulations of Lamivudine/Zidovudine/Nevirapine Using Healthy Adult Volunteers
Study Overview
Status
Detailed Description
Volunteer Selection and Size: The International Conference on Harmonization (ICH) guideline E11 on clinical investigation of medicinal products in the pediatric population suggests that for relative bioavailability comparison of pediatric formulations, adult subjects may be used. Therefore, the study will be performed in a minimum of 24 healthy adult subjects. However, 29 healthy adults will be enrolled to allow for two possible drop-outs and for three subjects that may develop hypersensitivity to nevirapine which is known for its hypersensitivity side effect, in form of rashes.
In anticipation of such reactions,10% more of the 26 subjects will be added to the group. This will make a total of 29 volunteers during the study. Advertisements announcing the study will be posted at the Bowen University Teaching Hospital two months before the commencement of the study to invite volunteers.
Informed Consent Procedure: The volunteers will be screened using a questionnaire (see attached). The language of communication will be English or a local language used by the community. Researchers will explain to the volunteers on an individual basis, the nature of the study, what would be expected of them and their rights. Volunteers may choose to drop out of the study at any time without any restrictions. Volunteers will be informed that the screening procedure also includes physical examination and laboratory test. Following informed consent, using Consent to Participate Form (see attached) and counseling, volunteers may be enrolled for the study.
A baseline laboratory tests for: packed cell volume, white blood cell count with differentiation, platelet estimation, liver function (aspartate aminotransferase [SGOT], alanine aminotransferase [SGPT]), renal function (serum creatinine), blood urea nitrogen (BUN), pregnancy test (females only), HIV/AIDS, and hepatitis B and C tests will be done two weeks prior to dosing. Volunteers may not consume alcohol, tobacco, caffeine containing products, herbal or other drugs during the study.
Eligibility: The inclusion criteria are as follows: Adult males and females found normal on the basis of a pre-trial physical examination, medical history and the results of blood biochemistry and hematology tests; subject is competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study; willingness to be hospitalized for a 24-hour intensive sampling period.
Exclusion criteria:
- Hypersensitivity to study drugs, alcoholism, anemia, evidence of pregnancy
- Abnormal laboratory test; smokers;
- Any clinically significant diseases or findings during the screening medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
- Treatment with experimental or prescribed drugs within 30 days prior to the beginning of the study
Confidentiality: Volunteer's name as it appears on the questionnaire will be linked to an identification number. All other documents will have only the identification number instead of your name. The name will not be used in any public document. All written materials and consent forms will be stored in a locked file in the researcher's office. All materials will be destroyed by shredding five years after the completion of the research.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Oyo State
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Ogbomoso, Oyo State, Nigeria, 234
- Bowen University Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The eligibility criteria included adults between 22 and 55 years;
- Healthy as determined on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and hematology tests;
- Subject was competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study;
- Willing to be hospitalized for the 24-hour intensive sampling period.
Exclusion Criteria:
- The exclusion criteria was hypersensitivity to study drugs;
- Abnormal laboratory biochemistry values;
- Smokers;
- Any clinically significant diseases or findings during the screening, medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
- Treatment with experimental drugs within 30 days prior to study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Reference
Co-administered liquid mixture of Epivir® (lamivudine) solution, Retrovir® (zidovudine)and Viramune® (nevirapine)
|
12 mL of Epivir® (lamivudine) 10 mg/mL solution plus 24 ml of Retrovir® (zidovudine) 10 mg/mL syrup plus and 20 mL of Viramune® (nevirapine) of 10 mg/mL
Other Names:
|
Active Comparator: Test product
Fixed dose combination of lamivudine, zidovudine and nevirapine reconstitutable suspension
|
20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension
Other Names:
Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.
Other Names:
|
Active Comparator: Test Product
Fixed dose combination combination (Lamivudine, Zidovudine and Nevirapine)tablet
|
20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension
Other Names:
Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioequivalence between the tests and reference drugs
Time Frame: 90 days
|
The BE criterion established by the Food and Drug administration requires that the 90 % confidence interval of the ratio of suspension or tablet/co-administered liquid mixtures of the individual drugs for all the three parameters (Cmax, AUC0-t, AUC0-∞)should lie within 80 to 125 % range.
|
90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Moji C Adeyeye, Ph.D, Elim Pediatric Pharmaceuticals Inc. and Roosevelt University
- Study Director: Daniel A Gbadero, MD, Bowen University Teaching Hospital, Ogbomoso, Nigeria
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Nevirapine
- Lamivudine
- Zidovudine
Other Study ID Numbers
- RU 2010-73
- 2010-73 (Other Identifier: Roosevelt University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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