None listed
Conditions
Interventions
Intervention1: Endoxifen Tablets 0.5 mg, 1 mg, 2 mg or 4mg (2 tablets of 2mg).: Single dose administration of
Endoxifen Tablets 0.5 mg, 1mg, 2mg and 4 mg (2 tablets of x 2 mg).
Each tablet containing
Sponsors
Lambda Therapeutic Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Healthy human male or female between 18 - 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India. Having a Body Mass Index (BMI) between 18.5- 24.9 (both inclusive), calculated as weight in kg / height in m2. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings. Able to comply with study procedures, in the opinion of the Principal Investigator. Able to give written consent for participation in the trial. In case of female subjects: a) They must have been surgically sterile at least for 6 months prior to participation in the trial. Or b) Those who are of child bearing potential must be using a suitable and effective double barrier contraceptive method or intra uterine devices during the study
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to endoxifen, tamoxifen or any related drug. Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. Ingestion of a medication at any time in 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator. Or ingestion of any enzyme inducer or inhibitor drug within 28 days of dosing. Any history or presence of asthma (including aspirin viii. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. History of psychiatric disorders. A history of difficulty with donating blood. Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the study medicine. Note: In case the blood loss is ≤ 200 mL; subject may be enrolled 60 days after blood donation. Testing positive in pregnancy test (females) Nursing mothers (females)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (i) To assess the safety and tolerability of Endoxifen tablets in healthy volunteers. (ii) To evaluate the pharmacokinetics of Endoxifen after single oral dose administration of Endoxifen Tablets. (iii) To examine pharmacokinetics of Endoxifen formed from reference drug productTimepoint: Nil | — |
Secondary
| Measure | Time frame |
|---|---|
| Brief clinical examination including, vital signs (Blood pressure, radial pulse, respiratory rate, oral body temperature): o after check-in o 1, 3, 6, 12, 24, 36, 48, 84 hrs post dose. o before checkout o on day 13 of the dosing o at the end of study (after the last ambulatory sample).Timepoint: Nil | — |
Countries
India
Contacts
Public ContactDrManjunath
Lambda Therapeutic Research Ltd
Outcome results
None listed