| Eligibility |
Inclusion Criteria:
Age 21-50 years. Body-mass index 18.5 to 30.0 kg/m2 inclusive. (Minimum of 50 kg weight for
males and 45 kg for females).
Subject is available for the whole study period and gave written informed consent.
Normal physical examination or being assessed as clinically non-significant by the
attending physician.
Normal neurological, cardiovascular, cerebrovascular, gastrointestinal and respiratory
systems.
Normal Vital Signs. Normal Electrocardiogram (ECG). Subjects refraining from alcohol use,
other study medication and drugs.
Lab test inclusion criteria:
On Screening Chemistry, Hematology and Urine laboratory screening results within the normal
range, or being assessed as clinically non-significant by the attending physician.
Normal Liver and kidney function test.
Exclusion Criteria:
Lab test exclusion criteria
On screening
1. Positive serology test.
2. Chemistry, Haematology and Urine laboratory screening results not within the normal
range, or being assessed as clinically significant by the attending physician
3. Abnormal Liver and kidney function test.
4. Positive hCG for female subjects.
On Admission:
1. The intake of caffeine, xanthene, or CO2-containing beverages within 24 hours of drug
administration.
2. Consumption of alcohol, grapefruit or grapefruit containing products within 7 days of
drug administration
3. Ingestion of any supplements like vitamins or herbal products within 7 days prior to
each drug administration study.
4. Clinically significant illness 4 weeks before study Period I
5. Exhausting physical exercise in the last 24 hours (e.g. weight lifting) or any recent
significant change in dietary or exercise habits.
6. Abnormal vital signs and being assessed as clinically significant.
7. Vomiting, diarrhea on admission.
8. Subjects with concurrent medication must be taken 14 days before drug administration
and during study period especially warfarin, aspirin, non-steroidal anti-inflammatory
drugs, levodopa, antipsychotic medicinal products, fibrates, ciclosporin, fusidic acid
(a medicine for bacterial infection), orally and or by injection.
9. Participation in another bioequivalence study and/or clinical trials within 80 days
prior to the start of this study Period.
10. Have been taking medication that could affect the investigated drug product: a)
Regular consumption of drugs during the b) consumption of enzyme stimulating or
inhibiting drugs (e.g.
Barbiturates, Carbamazepine, Phenytoin, Amphetamine, Benzodiazepine, cannabinoid,
cocaine, opiates, phencyclidine and methadone) during two weeks before the study
initiation.
11. Subject taking medications that belongs to strong CYP3A4 inhibitors (including, but
not limited to, ketoconazole, itraconazole, voriconazole, clarithromycin,
telithromycin, ritonavir) or inducers (e.g., phenytoin, rifampicin, carbamazepine,
phenobarbital and St. John's Wort) within 4 weeks prior to study.
12. Subject taking monoamine oxidase inhibitors medications.
13. Subject taking selective serotonin reuptake inhibitor/serotonin-norepinephrine
reuptake inhibitors (SSRI/SNRI) medications.
14. Subject taking uridine diphosphate glucuronosyl transferase enzyme modulators
medication.
Pre-dose:
1. Pre-dosing blood pressure less than 110/70 mmHg.
2. Pre-dosing heart rate less than 70 beats per minute.
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