twenty healthy volunteers
Conditions
Interventions
One tablet of clopidogrel 75 mg both generic and reference product was orally administered to all subjects with water 250 ml in fasted state as designed by a two-
period randomized cross over study. ,One tablet of clopidogrel 75 mg both generic and reference product was orally administered to all subjects with water 250 ml in fasted state as designed by a two&
period randomized cross over study.
Other,Other
clopidogrel generic,clopidogrel reference
Sponsors
none
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Thai male or female, aged 18 to 45 years. 2. BMI is within 18-25 kg/m2 3. Subjects, who are healthy by medical history, physical examination and vital signs. 4. Subjects, whose screening visit laboratory values of blood tests. 5. Female subject who is in childbearing potential must have serum β-HCG negative and agrees to use an acceptable birth control method from visit 1 to the last visit. 6. Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects who are with a history/evidence of allergy or hypersensitivity to pregabalin or any related drug. 2. Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of the study. 3. Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least one day before the study and until the completion of the study phase. 4.Subjects who are with a history of alcoholic (more than 2 years) or moderate drinkers (more than 3 drinks per day – one is equal to one unit of alcohol. 5. Subjects who receive of any medical prescription within 14 days before the first administration of the study drug, especially drug related to the study drug metabolizing enzyme. 6. Female subjects who are pregnant or breast feeding. 7. Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 month prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics at 2 week after drug admistration liquid chromatography tandem mass spectrometry (LC-MS/MS) and light transmission aggregometor (LTA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics 6 months after end of intervention liquid chromatography tandem mass spectrometry (LC-MS/MS) and light transmission aggregometor (LTA) | — |
Countries
Thailand
Contacts
Public ContactMalinee Chunsangchan
Department of Pharmacology, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed