Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05532332
Other study ID # ALZ-B-20-023
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 18, 2021
Est. completion date February 11, 2021

Study information

Verified date September 2022
Source Future University in Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each Fluoxetine 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.


Description:

Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 21 days. Fluoxetine plasma concentrations were determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 11, 2021
Est. primary completion date February 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Written informed consent is obtained for the study. - Age 18 - 55 years - Body mass index between 18.5 and 30 kg/m2 - Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination. - Vital signs without significant deviations. - All laboratory screening results are within the normal range or clinically non-significant Exclusion Criteria: - History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk, or interfere with the ability of the subject to complete the study in the investigator's opinion. - History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer. - Any confirmed significant allergic reactions against any drug or multiple allergies. - Clinically significant illness 28 days before study phase I. - Alcohol or any solvent intake. - Regular use of medication. - Positive urine screening of drugs of abuse. - Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study. - History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout. - Blood donation within the past 60 days. - Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fluoxetine 10 mg capsules
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
Prozac® 10 mg capsules
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg

Locations

Country Name City State
Egypt Future Research Center (FRC) Cairo

Sponsors (1)

Lead Sponsor Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum plasma concentration (Cmax) Cmax is observed as the maximum of Fluoxetine peak concentration (Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
Primary Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h) The AUC (0-72h) is the area under the Fluoxetine plasma concentration with time curve from the time of dosing to the 72-hour sample (Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
Secondary Maximum time (Tmax) Time until Cmax is reached (Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1