Phase 1
Completed N=26
Avandamet Bioequivalence Study Brazil - Fed Administration
Source: ClinicalTrials.gov NCT01332071 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: AUC0-t of Rosiglitazone Maleate — 1731.22; 1770.93 ng per hour per ml (ng.h/ml)
Summary
The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-t of Rosiglitazone Maleate |
1731.22; 1770.93 | — |
| PRIMARY Cmax of Rosiglitazone Maleate |
265.45; 270.97 | — |
| PRIMARY AUC0-infinity of Rosiglitazone Maleate |
1776.28; 1825.35 | — |
| PRIMARY AUC0-t of Metformin Hydrochloride |
9623.4; 10074.4 | — |
| PRIMARY AUC0-infinity of Metformin Hydrochloride |
10419.8; 11063.7 | — |
| PRIMARY Cmax of Metformin Hydrochloride |
1623.6; 1663.9 | — |
Eligibility Criteria
EXCLUSION CRITERIA
- The volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
- History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism;
- History of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;
- Hypo or hypertension of any etiologic that needs pharmacologic treatment;
- The results of the laboratory exams are out of the values considered as normal according this protocol's rules, unless that they are considered as clinically irrelevant by the investigator;
- Has history of alcohol or drugs abuse;
- History of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;
- Use of MAO inhibitors two weeks before the start of treatment; - Use of inhibitors of 5-TH reuptake,
- Pregnancy or breastfeeding,
- Smoking;
- Use of regular medication within 4 weeks prior to study iniciation;
- Use of experimental drug or participation in any clinical study within 6 months prior to study iniciation.
INCLUSION CRITERIA
- Age between 18 and 50 years;
- Body mass index ≥ 18, 5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);
- Good health conditions;
- Obtain the Informed Consent's signed.
Data sourced from ClinicalTrials.gov (NCT01332071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.