Healthy
Conditions
Brief summary
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
Detailed description
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Zolpidem Tartrate Tablets containing Zolpidem Tartrate 10 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Ambien® Tablets 10 mg containing Zolpidem Tartrate 10 mg (Reference , Sanofi-Synthelabo Inc) in Healthy Human Volunteers Under Fed Condition.
Interventions
DRUG'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
Sponsors
Torrent Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* The subjects who qualify for the study should meet the following inclusion criteria. 1. Male and female subjects in the range of 18 - 45 years of age. 2. Subjects having Body Mass Index (BMI) in a range of 18.5 to 24.9. 3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature) 4. Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray. 5. Willingness to follow the protocol requirement as evidenced by written, informed consent. 6. Agreeing to, not using any medication prescription and over the counter medicines including vitamins and minerals for 14 days prior to study and during the course of the study. 7. No history or presence of significant alcoholism or drug abuse in the past one year. 8. Non-smokers, ex smokers and light smokers will be included. Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.
Exclusion criteria
* The subjects who qualify for the study should not meet the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. | The maximum or peak concentration that the drug reaches in the plasma |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. | The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t) |
| The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) | plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. | The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant. |
Countries
India
Participant flow
Pre-assignment details
healthy, normal subjects
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Torrent's Zolpidem Tartrate Tablets 10 mg and Ambien® 10mg tablets | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 27.6 years STANDARD_DEVIATION 7.48 |
| Region of Enrollment India | 30 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 30 | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)
Time frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | 734.29 ng.hr/mL | Standard Deviation 416.53 |
| Active Comparator | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | 705.45 ng.hr/mL | Standard Deviation 356.65 |
Primary
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that the drug reaches in the plasma
Time frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Maximum Plasma Concentration (Cmax) | 130.58 ng/mL | Standard Deviation 40.61 |
| Active Comparator | Maximum Plasma Concentration (Cmax) | 124.53 ng/mL | Standard Deviation 37.48 |
Primary
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Time frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) | 776.65 ng.hr/mL | Standard Deviation 484.2 |
| Active Comparator | The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) | 734.01 ng.hr/mL | Standard Deviation 384.9 |