An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiwan Liposome Company
ClinicalTrials.gov Identifier:
NCT01652859
First received: July 20, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different liposomal amphotericin B injections after single IV infusion at the same dose in normal healthy subjects.


Condition Intervention Phase
Normal Healthy Subjects
Drug: Liposomal Amphotericin B
Drug: AmBisome
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open-label, Randomized, Balanced, Crossover Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Taiwan Liposome Company:

Primary Outcome Measures:
  • The bioequivalence of two different liposomal amphotericin B injections [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    90% CI of Cmax and AUCinf of Liposomal and non-liposomal Amphotericin B between Ambil and AmBisome within 80.00%~125.00%.


Enrollment: 36
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomal Amphotericin B
Generic drug
Drug: Liposomal Amphotericin B
Active Comparator: AmBisome
RLD
Drug: AmBisome

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must be adults (> 20 years old) in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
  2. Vital signs (after 3 minutes resting in a upright position) which are within the following ranges: Ear body temperature between 35.0-37.5 °C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm
  3. Fasting blood glucose < 100 mg/dL.
  4. Body weight must be above 50 kg for men and 45 kg for women and within 20% of ideal body weight.
  5. Negative urine drug screen at clinic check-in before each dosing
  6. Able to sign informed consent prior to study.
  7. Able to communicate well with the investigator and comply with the requirements of the study.
  8. Pregnancy tests (female only): negative reaction

Exclusion Criteria:

  1. Use of any prescription or over the counter medication within 14 days prior to investigational products administration; with the exception of acetaminophen (not more than 2 g/day) or vitamins.
  2. A plan to take concomitant medications while enrolled in the study, with the exception of acetaminophen (not more than 2 g/day) or vitamins.
  3. Presence of any acute or chronic medical condition within 2 weeks prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs. Evidence of impaired renal function as indicated by clinically significant abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria) as judged by the investigator. Evidence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an clinically significant abnormal liver function profile such as GOT, GPT, g-GT, alkaline phosphatase, serum bilirubin, HBs Ag, or HCV Ab as judged by the investigator.
  4. Hemoglobin less than 12 g/dL
  5. Participation in any clinical investigation within 2 months or 5 half-lives, whichever is longer, prior to investigational products administration.
  6. Donation or loss of more than 500 mL blood within 3 months prior to investigational products administration.
  7. Subject is known for HIV infected.
  8. Known allergy or hypersensitivity to amphotericin B or its analogs.
  9. History of drug or alcohol abuse within 12 months prior to investigational products administration ; current consumption of alcohol in excess of 28 units/week (one unit is 6 oz of beer, ½ oz of hard liquor, or 2 oz of wine)
  10. Subjects who, in the opinion of the investigator, should not participate in the study or may not be capable of following the study schedule for any reason.
  11. Consumption of more than 36 to 40 oz (1.1-1.2 L) of caffeine-containing beverages per day
  12. Consumption of any products containing grapefruit in the 3 days before clinic check-in.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Taiwan Liposome Company
ClinicalTrials.gov Identifier: NCT01652859     History of Changes
Other Study ID Numbers: TLC166.2
Study First Received: July 20, 2012
Last Updated: November 25, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014