None listed
Conditions
Interventions
Intervention1: G44: Single oral dose of G44
200 mg
group 1
Intervention2: G44: Single oral dose of G44
600 mg
group 2
Intervention3: G44: Single oral dose of G44
1200 mg
group 3
Intervention4: G44: Single oral dose of G44,
1800 mg
group 4
Control Intervention1: Gabapentin: Single oral dose of Gabapentin
100 mg
group 1
Control Intervention2: Placebo: Single oral dose
Control Intervention3: Gabapentin: Single oral dose of Gabapentin
300 mg
group 2
Control Intervention4: Gabapentin: Single oral dose of Gabapentin
600 mg
group 3
Control Intervention5: Gabapentin: Single oral dose of Gabapentin
900 mg
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Availability of subject for the entire study period and willingness to adhere to protocol requirements. 2. Healthy male and female subjects, 18 to 45 years of age inclusive, subjects having weight at least 50Kg and the subjects body mass index (BMI) must be within 18.5 - 25.0 (Kg/m2) (inclusive). 3. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21days prior to commencement of the study. 4. Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance. 5. Informed consent form given in written form. 6. Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1.History or presence of significant: 1.1.Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Gabapentin and/or any related compounds etc. 1.2.Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 1.3.Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. 1.4.Smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products (more than or equal to 4 chews/day). 1.5.History of difficulty in swallowing or coming for follow up. 1.6.Clinically significant illness within 4 weeks before the start of the study 1.7.Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks preceding the study 1.8.Female subject who is pregnant, lactating or likely to become pregnant or have a positive pregnancy test at screening and prior to each period. 1.9.Positive result to HIV, HCV and HBsAg. 1.10.Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Valproic acid, etc.) in the previous 30 days before day 1 of this study. 1.11.Abnormal 12 lead ECG, X-ray. 2.Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study. 3.Participation in another clinical trial within the preceding 90 days of study starts. 4.Subjects who have: 4.1.Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg 4.2.Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the principal investigator. 4.3.Pulse rate below 60/min. or above 100/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, vital signs, clinical laboratory tests, ECGTimepoint: screening, check-in, in-study, check-out and post-study | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic ParametersTimepoint: In-study | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed