Bioavailability Study of Amitriptyline Hydrochloride Tablets

NCT03646526 | Completed Phase 1

• 1 other identifier: ZYYY-AMTL-BE-2018-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Main Objectives: In Chinese healthy subjects under both fasting and postprandial conditions, amitriptyline hydrochloride tablets (size: 25 mg) produced by Sandoz Inc., US Orange Book, were used as reference preparations. A single-dose oral reference preparation and amitriptyline hydrochloride tablets (size: 25 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd., and the calculation of the drug by the time course of amitriptyline and its active metabolite, nortriptyline, in vivo The kinetic parameters were compared, and the relative bioavailability of the two was compared to evaluate bioequivalence, which provided the basis for the bioequivalence study of amitriptyline hydrochloride tablets by Hunan Dongting Pharmaceutical Co., Ltd. Secondary Objective: To monitor the safety of fasting and postprandial oral test and reference preparations.

Conditions

Depressive Disorder

Keywords

Amitriptyline hydrochloride

Outcome Measures

Primary Outcomes (4)

• Cmax

  Maximum Observed Plasma Concentration for amitriptyline

  144 hours post-dose on Day 1,22

• Tmax

  Time to Reach the Maximum Plasma Concentration

  144 hours post-dose on Day 1,22

• AUC(0-inf)

  Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for amitriptyline

  144 hours post-dose on Day 1,22

• AUC(0-144h)

  Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for amitriptyline

  144 hours post-dose on Day 1,22

Study Arms (2)

Fast group

EXPERIMENTAL

During the study session, healthy subjects will be administered a single dose of Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） or Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） under fasting condition . cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） or cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）

Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）; Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）

Feeding group

EXPERIMENTAL

During the study session, healthy subjects will be administered a single dose of Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） or Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） under feeding condition. cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） or cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）

Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）; Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）

Interventions

Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） DRUG

Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）is a generic product manufactured by Hunan Dongting Pharmaceutical Co., Ltd.

Fast group; Feeding group

Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） DRUG

Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）is a generic product manufactured by Sandoz Inc;

Fast group; Feeding group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years old (including 18 and 45 years old), both male and female;
• Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more than 45kg (including 45kg); Body mass index \[BMI = body weight (kg)/height (m)2\] is in the range of 19 to 26 kg/m2;
• According to past medical history, comprehensive physical examination and prescribed laboratory tests, the investigator determined that Healthy subjects;
• Women of childbearing age have a negative blood pregnancy test and are effective from 14 days before dosing to 6 months after the end of study Appropriate contraceptive measures;
• Male volunteers must take effective and appropriate 14 days before dosing until 6 months after the end of the study.
• The contraceptive measures and agrees not to perform sperm donation within six months from the administration until the end of the study;
• Fully understand the purpose of the test, the nature of the test, the study procedures, and possible adverse reactions.
• Willing to participate in the trial and sign the informed consent form (the process of obtaining the informed consent accords with GCP regulations);
• Communicate well with the researcher, follow the requirements of the entire study, and be willing to stay in the Phase I clinical research ward as required.

You may not qualify if:

• Can not tolerate venipuncture, who have a history of dizziness and pinching blood;
• Clearly have a history of allergies to the drug ingredients or similar species or to two or more other drugs Sensitive history and highly sensitive to food and environmental substances;
• Have a history of any serious clinical illness, including but not limited to digestive system, cardiovascular system, respiratory system, Urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system Patients with a history of diseases and metabolic disorders;
• Laboratory tests (blood routine, urine routine, blood chemistry, etc.) and chest X-ray and ECG within 2 weeks before the test Those who have abnormal clinical findings
• Hematological screening (HIV antibody or HBV surface antigen or HCV antibody or TP antibody) positive;
• women who are breastfeeding, pregnant or plan to become pregnant recently;
• Female subjects are in lactation or positive pregnancy test during the screening period or during the trial;
• Male and female subjects who have not taken effective contraception or whose spouse plans to have children within six months;
• Persons with mental or legal disabilities;
• Screening for history of prescription drug abuse and/or history of illegal drug abuse within the first 6 months of screening;
• A person who has a history of alcohol abuse within the first 6 months of screening, ie drinking more than 14 units of alcohol per week (1 unit = 12 ounces or 360 mL beer, 1.5 ounces or 45 mL alcohol 40% spirits, 5 ounces or 150mL wine);
• Smoke more than 5 cigarettes per day within 6 months before screening;
• positive for substance abuse screening or alcohol testing;
• Those with a history of hospitalization or surgery within 3 months prior to screening (excluding appendicitis);
• Participate in other drug clinical trials within 3 months before screening;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Hunan DongtingPharm.Co.Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital,ZheJiang Univercity

Hanzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Zhai Y, Wu L, Zheng Y, Wu M, Huang Y, Huang Q, Shentu J, Zhao Q, Liu J. Bioequivalence Study of Amitriptyline Hydrochloride Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions. Drug Des Devel Ther. 2020 Aug 4;14:3131-3142. doi: 10.2147/DDDT.S258173. eCollection 2020.

  PMID: 32801649 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jian LIU, Master

  The First Affiliated Hospital,ZheJiang Univercity

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: August 24, 2018
• Study Start: April 4, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-01

Locations

CN (1)