A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01618877
First received: June 11, 2012
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Volunteers |
Drug: Levetiracetam Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Area under the plasma drug concentration-time curve over a dosing interval (AUCτ) [ Time Frame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 ] [ Designated as safety issue: No ]The AUCτ is the area under the plasma concentration, after the last intravenous (iv) dose, versus time curve observed during the dosing interval τ.
- Maximum measured plasma concentration (Cmax) [ Time Frame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 ] [ Designated as safety issue: No ]The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
Secondary Outcome Measures:
- Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv)) [ Time Frame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 ] [ Designated as safety issue: No ]The value of the plasma concentration at the end of the 45-min iv infusion is directly obtained from the experimental data of plasma concentration versus time curves.
- Minimum plasma concentration over dosing interval after intravenous (iv) infusion (Cmin) [ Time Frame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 ] [ Designated as safety issue: No ]
- Terminal half-life (t1/2) [ Time Frame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 ] [ Designated as safety issue: No ]The terminal half-life associated with the terminal rate constant λ_z is calculated as: ln2/λ_z. λ_z is the first order rate constant of elimination.
| Enrollment: | 24 |
| Study Start Date: | May 2012 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Levetiracetam iv infusion
Levetiracetam intravenous (iv) infusion.
|
Drug: Levetiracetam
Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B).
Other Name: Keppra
|
| Placebo Comparator: Placebo infusion |
Other: Placebo
15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).
|
Detailed Description:
The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess the pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Chinese, age 18-40, weight ≥ 50 kg
- Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test
Exclusion Criteria:
- History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
- History or presence of drug addiction or excessive use of alcohol
- Symptomatic or asymptomatic Orthostatic Hypotension at screening
- Current smokers and former smokers
- Heavy caffeine drinker
- History of frequent and severe headache
- Any drug treatment
- Subjects who are known to have Serum Hepatitis or who are carriers of the Hepatitis B surface antigen, or Hepatitis C antibody or who are HIV positive
- Subjects on a controlled sodium diet
- Subject has made a blood donation or had a comparable blood loss
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01618877 History of Changes |
| Other Study ID Numbers: | N01362B |
| Study First Received: | June 11, 2012 |
| Last Updated: | August 2, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by UCB, Inc.:
|
Keppra Levetiracetam intravenous Multiple dose Safety Pharmacokinetics Chinese healthy volunteers |
Additional relevant MeSH terms:
|
Etiracetam Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013