None listed
Conditions
Brief summary
In the present study the bioequivalence of two different drugs, the same type of pharmaceutical form at the same dose, containing the same drug (amfepramone), but may have different excipients was evaluated. Compared if their plasma pharmacokinetic parameters, expressed as area under curve from time zero to the last measurement (AUC0-t); area under curve from time zero to infinity (ABC0-8); maximum plasma concentration (Cmax), have similarity to each other in 36 healthy male and females volunteers; and thus determine if they are bioequivalent.
Interventions
Test and Reference drugs, in a single oral dose (75 mg) in 2 periods under fasting conditions and 2 periods under food conditions From the signing of the informed consent to the medical discharge
Test drug: Amfepramone
Reference drug: Neobes Amfepramone
The study includes two designs (fasting and food) with two periods each of approximately 36 hours of internment and a post-discharge sample taking of 48 hours, in each period of both designs. Between each internment there are a period of 2 week
Test and Reference drugs, in a single oral dose (75 mg) in 2 periods under fasting conditions and 2 periods under food conditions From the signing of the informed consent to the medical discharge Test drug: Amfepramone Reference drug: Neobes Amfepramone The study includes two designs (fasting and food) with two periods each of approximately 36 hours of internment and a post-discharge sample taking of 48 hours, in each period of both designs. Between each internment there are a period of 2 weeks of washout. The study begins with two periods under fasting conditions (2x2x2 design under fasting conditions). After a previous fast of at least 10 hours, the sample of time 0.00 will be obtained. Next, 75 mg of amfepramone will be administered, orally with 250mL of water at room temperature. Subsequently, the design of two periods in post-prandial conditions will be continued (2x2x2 design with food). After a previous fast of 10 hours, the sample of time 0.00 will be obtained. Likewise, 30 minutes before dosing, each research subject will receive a standard breakfast; the research subjects will have 30 minutes to finish all the breakfast and immediately afterwards the medication will be administered orally, with 250mL of water. Breakfast is high in calories (approximately 923 kcal: 506.19 kcal fat, 241.51 kcal carbohydrate, 175.3 kcal protein) and high in fat (aprosoimadamente 54.8%). The staff of the clinical pharmacology center is responsible for the preparation and dispensing of medicines (test or reference) must wear protective glasses, gloves, gown. the medication must always keep its identification label (container label). The study coordinator must verify that the data on the label of the medication container correspond to those of the research subject to whom the medication is delivered. The medical collaborator indicates to the research subjects when they should ingest the medication. The clinical collaborator verifies the swallowing of the medication visualizing the oral cavity of each research subject in charge with the lamp for review and informs the coordinator of the study of the clinical unit of any anomaly. In conclusion throughout the study there is a direct observation by study personnel.
Sponsors
Investigación Farmacéutica, S.A. de C.V.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
· Healthy male and female research subjects will be included in the study. · Age between 18 and 55 years old. · A BMI (Body Mass Index) between 18.0 to 27.0 kg/m2. · To have signed the authorization for clinical examinations, as well as the informed consent before carrying out any procedure belonging to the study. · The volunteer agrees to take the necessary measures to avoid conception during the entire study, this commitment is established in the letter of commitment of non-pregnancy and informed consent. · Negative test results to determine substances of abuse, made during the selection process/beginning of each study period. · Negative results in pregnancy tests performed during the selection/start process of each study period. · Negative results in the tests for Ab HIV, AgsHB, Ab HCV and RPR (lictic test). · Values of clinical biochemical tests: Hematic Biometrics, Urinalysis, Biochemical Profile: (Glucose, Ureic Nitrogen, Urea, Creatinine, Uric Acid, Cholesterol, Triglycerides, Total Proteins, Albumin, Globulin, Bilirubin (total, indirect and direct), Phosphatase Alkaline, Lactic Dehydrogenase, AST, ALT, Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), are in a range between the minimum value and the maximum value of the normal values accepted for said tests. · In cases of exception, a candidate may be accepted in which any of the aforementioned tests exceeds the maximum and minimum values accepted as normal, as long as it is an isolated value and there are no other statements presuming that the limit value was related with a future illness, or the remnant of another. These must be approved by the clinical area and declared as "clinically insignificant". · Electrocardiogram free of anomalies; It will be valid for three months from the date of execution.
Exclusion criteria
·Electrocardiographic abnormalities · Positive results in the examination of substance abuse, during the pre-selection/beginning of each period. · Positive results in pregnancy tests performed during the selection/start process of each study period. · Positive results in tests for Ab HIV, AgsHB, Ab HCV, RPR. · Personal or family history of allergy to the drugs in question, chemically related drugs, or food allergies provided in the protocol diet. · Subjects in which the medication in question is contraindicated. · Subjects intolerant to venipuncture. · Tobacco abuse (more than 5 cigarettes a day) · Drug addiction. · People subjected to a medical treatment. · Women in breastfeeding period. · People presenting swallowing or phagophobia problems. · People with a history of glaucoma, hypertension, anorexia, thyroid problems. · People presenting any obstructive disease of the urinary tract or gastrointestinal tract. · Existence of concurrent or intercurrent disease. · Existence of doubt based on the veracity of the answers in the interrogation. · Have participated in studies of bioequivalence or bioavailability according to the Program of Research Subjects of COFEPRIS, or have donated blood 3 months before this study. · Presence of a medical condition that requires regular medication (prescription or free sale) with systemic absorption. · Have smoked (more than 5 cigarettes a day); consumed alcoholic beverages; drinks with xanthines (cola drinks, coffee, tea, chocolate, energy drinks, etc.); grapefruit, natural juice of grapefruit and / or its derivatives; food prepared on charcoal, food supplements, herbal remedies or have used any other medicine (example: inhibitors of MAO monoamine oxidase or beta-blockers, tricyclic antidepressants, anti-flu drugs containing ephedrine, anorexigenic etc.) within 48 hours before the study . · History of drug addiction or alcohol abuse. · Labor subordination between the researcher and the research subject. · Present pressure> 140 mm Hg (systolic) or> 90 mm Hg (diastolic). · Present values in clinical laboratory tests outside of clinically significant range. · Did not sign the Informed Consent and the commitment of non-pregnancy, corresponding to the study. Finally, all research subjects who do not comply with the indications regarding diet, habits, who have mental incapacity to follow instructions and make decisions, who do not meet all the inclusion criteria described above and finally, who disagree with Official Mexican Standard NOM-177-SSA1-2013.
Outcome results
None listed