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Bioequivalence of Two Formulations of Acyclovir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255734
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
Yung Shin Pharm. Ind. Co., Ltd.

Brief Summary:
Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg) after Intravenous Infusion in Healthy Volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Acyclovir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of Two Formulations of Acyclovir
Study Start Date : April 2014
Actual Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zovirax Drug: Acyclovir
Experimental: Virless Drug: Acyclovir



Primary Outcome Measures :
  1. Plasma drug concentration [ Time Frame: Day 1, Day 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult male or female subjects between 20 to 45 years of age
  • Body weight within 80 to 120 percentages of ideal body weight and higher than or equal to 50 kg for male subjects and 45 kg for female subjects
  • Acceptable medical history and physical examination including no particular clinically significant abnormality in x-ray and ECG results within six months prior to period I dosing.no particular clinical significance in general disease history within two months prior to period I dosing
  • Acceptable vital signs within normal limits or considered by the investigator or physician to be of no clinical significance at screening, which includes pulse rate, blood pressure and body temperature
  • Acceptable clinical chemistry determinations within normal limits or considered by the investigator or physician to be of no clinical significance within two months prior to Period I dosing, which includes AST , ALT ,GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride
  • Acceptable hematology within normal range or considered by the investigator or physician to be of no clinical significance within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets
  • Acceptable urinalysis within normal limits or considered by the investigator or physician to be of no clinical significance within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin and protein
  • Female subjects of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigators or surgically sterile bilateral tubal ligation, bilateral oophorectomy or hysterectomy performed on the subject
  • Have signed the written informed consent to participate in the study

Exclusion Criteria:

  • A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic systems or psychiatric disease as determined by the clinical investigator
  • A clinically significant illness or surgery within four weeks prior to Period I dosing as determined by the investigator
  • History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years
  • History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant
  • Known or suspected history of drug abuse within lifetime as judged by the investigator
  • History of alcohol addiction or abuse within last five years as judged by the investigator
  • History of allergic responses to acyclovir, valacyclovir or any other related drugs
  • Evidence of chronic or acute infectious diseases
  • Female subjects demonstrating a positive urine pregnancy screen prior to the study
  • Female subjects who are currently breastfeeding
  • Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to Period I dosing. Examples of inducers include. piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine
  • Taking any prescription medications within four weeks or any nonprescription medications excluding flu vaccination within two weeks prior to Period I dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255734


Locations
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Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Sponsors and Collaborators
Yung Shin Pharm. Ind. Co., Ltd.
Investigators
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Principal Investigator: Po-Yen Chen, M.D. Taichung Veterans General Hospital
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Responsible Party: Yung Shin Pharm. Ind. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02255734    
Other Study ID Numbers: YSP-REH3002-01
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: September 2014
Keywords provided by Yung Shin Pharm. Ind. Co., Ltd.:
Volunteers
Additional relevant MeSH terms:
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Acyclovir
Antiviral Agents
Anti-Infective Agents