A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
This study is not yet open for participant recruitment.
Verified June 2011 by Dong Wha Pharmaceutical Co. Ltd.
Sponsor:
Dong Wha Pharmaceutical Co. Ltd.
Collaborator:
Chonbuk National University Hospital
Information provided by:
Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01367080
First received: June 2, 2011
Last updated: June 3, 2011
Last verified: June 2011
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Purpose
Randomized, Single dose, 2-way crossover, Open Study to compare the pharmacokinetics profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg after a single oral administration in healthy male volunteers
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Etravil 10mg Tablet Drug: Etravil 25mg Tablet |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Clinical Trials to Compare the Pharmacokinetics Profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg After a Single Oral Administration in Healthy Male Volunteers |
Resource links provided by NLM:
Further study details as provided by Dong Wha Pharmaceutical Co. Ltd.:
Primary Outcome Measures:
- Cmax of Amitryptiline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
- AUClast of amityptyline in plasma [ Time Frame: UP to 72H ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tmax of amityptyline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
- terminal half-life (t1/2) of amityptyline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
- CL/F of amityptyline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Etravil 10
Etravil 10mg given by oral administration intervention: drug: experimental Etravil 10mg
|
Drug: Etravil 10mg Tablet
sigle dose
|
|
Experimental: Etravil 25
Etravil 25mg given by orl administration intervention: drug: Experimental Etravil 25mg
|
Drug: Etravil 25mg Tablet
single dose
|
Eligibility| Ages Eligible for Study: | 19 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- a healthy adult male within the range of 19 to 50 years old at the time of screening
one with weight of more than 55kg, in the range of IBW 20%
- IBW(kg)={height(cm)-100}*0.9
- one who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.
Exclusion Criteria:
- one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
- one with glaucoma
- one with disorders of micturition include benign prostatic hyperplasia
- one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
- one who is allergic or has clinically significant allergic history to tricyclic antidepressants(TCA)
- one who shows the following result in vital sign: hypotension(systolic pressure ≤ 100mmHg or diastolic pressure ≤ 65mmHg) or hypertension(systolic pressure ≥ 150mmHg or diastolic pressure ≥ 95mmHg)
- one who has drug abuse history
- one who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
- one who has participated in other clinical study within 2 months before study drug administration
- one who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
- one who drank Over 21 units/week of alcohol(1 unit = 10g of pure alcohol) or subjects who would not be able to stop drinking alcohol during the hospitalization
- one who are heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization
- one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
- one with clinically significant observations considered as unsuitable based on medical judgment by investigators
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367080
Contacts
| Contact: Cheol-Hee Lim | 82-2-2021-9551 | cheolhee.lim@dong-wha.co.kr |
Locations
| Korea, Republic of | |
| Chonbuk National University Hospital. | Not yet recruiting |
| Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712 | |
| Contact: Min-Gul Kim, MD, PhD 82-63-250-2532 mgkim@ctcf2.com | |
| Contact: Cheol-Hee Lim, MS 82-2-2021-9551 cheolhee.lim@dong-wha.co.kr | |
| Principal Investigator: Kim Min-Gul, MD, PhD | |
Sponsors and Collaborators
Dong Wha Pharmaceutical Co. Ltd.
Chonbuk National University Hospital
Investigators
| Principal Investigator: | Min-Gul Kim, MD, PhD | Chonbuk National University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Cheol-hee Lim, Dong Wha Pharmaceutical Co. LTD. |
| ClinicalTrials.gov Identifier: | NCT01367080 History of Changes |
| Other Study ID Numbers: | DWETR-I-1 |
| Study First Received: | June 2, 2011 |
| Last Updated: | June 3, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Amitriptyline Amitriptyline, perphenazine drug combination Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 19, 2013