None listed
Conditions
Interventions
Intervention1: Extended/Sustained release metoprolol tablet: 50mg, one
Control Intervention1: Seloken (Metoprolol tartrate): 50mg once
Sponsors
Gattefosse India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Study subjects must have understood and provided written informed consent after the nature of the study has been fully explained 2.Adult healthy volunteers of either sex in the age group of 21 to 28 years. 3.Weight of the healthy volunteers between 55 to 75 kg and height between 5.5 ft to 6 ft. 4.The subjects have not taken any drug at least 15 days prior to the study and during the study. 5.No previous history of hepatic, gastrointestinal and hematological diseases, known allergic reactions especially to sulfa drugs, or asthma. 6.Free of obvious health problems as established by medical history and screening evaluations including clinical examination 7.Normal hematological and biochemical parameters (Hemoglobin, RBC count, WBC count, platelet count, random blood glucose, soudium, potassium, chloride, bicarbonate, blood urea, serum creatinine, total bilirubin, direct bilirubin, SGOT, SGPT, alkaline phosphatase,) and urine parameters (specific gravity, pH, protein, glucose, ketones, blood, RBC, WBC, cast) 8.Negative HBsAg and HIV by ELISA 9.Normal ECG and chest X-ray a. A female is eligible to enter and participate in study if she is of : Non child bearing potential (i.e, physiologically incapable of becoming pregnant, including any female who is post menopausal): or, Child bearing potential, has negative urinary pregnancy test (urine) at screening and agrees to one of the following: b. Complete abstinence from intercourse for the duration of the study c. Sterilization d. Sterilization of male partner e. Implant of levonorgestrel f. Oral contraceptive (combined or progesterone only) g. Any intrauterine device (IUD) with published data showing that the lowest failure rate is less than 1% per year h. Any other methods with published data showing that the lowest failure rate is less than 1% per year i. Barrier method only if used in combination with any of the above acceptable methods
Exclusion criteria
Exclusion criteria: 1. Consumption of any forms of tobacco, smoking, liquor drinking or drug abuse in the past 6 months 2. Subjects suffering from any psychiatric illness. 3. Subjects allergic to sulfa drugs. 4. Hypersensitivity to Metoprolol 5. Pulse rate after 10 minutes of supine position less than 50 per minute 6. ECG shows second / third degree heart block or sick sinus syndrome 7. Pregnancy confirmed by urine pregnancy test on the day of screening and on one day prior to enrollment 8. Nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To check the bio availability. The parameters used will be Cmax and AUC (0-t)Timepoint: Blood collections will be at pre dose, 1, 2, 4, 6, 8, 12, 15, 18, and 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactPrashant Kadam
Seth G S Medical College and KEM Hospital
Outcome results
None listed